CLINIMIX E

These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous useInitial U.S. Approval: 1997

Approved

Approval ID

8469d6fb-d6ef-476f-8cc3-0905192de0a8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 13, 2021

Manufacturers

FDA

Baxter Healthcare Corporation

DUNS: 005083209

FDA

Baxter Healthcare Company

DUNS: 005083209

Products 10

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-7020

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateApril 13, 2021

FDA Product Classification

INGREDIENTS (25)

LEUCINEActive

Quantity: 201 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

PHENYLALANINEActive

Quantity: 154 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

LYSINEActive

Quantity: 159 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

METHIONINEActive

Quantity: 110 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

ISOLEUCINEActive

Quantity: 165 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

VALINEActive

Quantity: 160 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

HISTIDINEActive

Quantity: 132 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

THREONINEActive

Quantity: 116 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

TRYPTOPHANActive

Quantity: 50 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

ALANINEActive

Quantity: 570 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

GLYCINEActive

Quantity: 283 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

ARGININEActive

Quantity: 316 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

PROLINEActive

Quantity: 187 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

SERINEActive

Quantity: 138 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

TYROSINEActive

Quantity: 11 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 216 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 112 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

DEXTROSEActive

Quantity: 5 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-7028

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateApril 13, 2021

FDA Product Classification

INGREDIENTS (25)

VALINEActive

Quantity: 247 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

HISTIDINEActive

Quantity: 204 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

THREONINEActive

Quantity: 179 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

GLYCINEActive

Quantity: 438 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

TYROSINEActive

Quantity: 17 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

PROLINEActive

Quantity: 289 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

LYSINEActive

Quantity: 247 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

ISOLEUCINEActive

Quantity: 255 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

TRYPTOPHANActive

Quantity: 77 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

ALANINEActive

Quantity: 880 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

LEUCINEActive

Quantity: 311 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

PHENYLALANINEActive

Quantity: 238 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

ARGININEActive

Quantity: 489 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 297 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

DEXTROSEActive

Quantity: 10 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

METHIONINEActive

Quantity: 170 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

SERINEActive

Quantity: 213 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 77 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-7034

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateApril 13, 2021

FDA Product Classification

INGREDIENTS (25)

LEUCINEActive

Quantity: 365 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

PHENYLALANINEActive

Quantity: 280 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

LYSINEActive

Quantity: 290 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

METHIONINEActive

Quantity: 200 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

ISOLEUCINEActive

Quantity: 300 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

VALINEActive

Quantity: 290 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

HISTIDINEActive

Quantity: 240 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

THREONINEActive

Quantity: 210 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

TRYPTOPHANActive

Quantity: 90 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

AlanineActive

Quantity: 1035 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

GlycineActive

Quantity: 515 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

ARGININEActive

Quantity: 575 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

PROLINEActive

Quantity: 340 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

SERINEActive

Quantity: 250 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

TYROSINEActive

Quantity: 20 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 340 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 59 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

DEXTROSEActive

Quantity: 20 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-7036

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateApril 13, 2021

FDA Product Classification

INGREDIENTS (25)

METHIONINEActive

Quantity: 200 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

ISOLEUCINEActive

Quantity: 300 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

LEUCINEActive

Quantity: 365 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

PHENYLALANINEActive

Quantity: 280 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

LYSINEActive

Quantity: 290 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

VALINEActive

Quantity: 290 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

HISTIDINEActive

Quantity: 240 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

THREONINEActive

Quantity: 210 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

TRYPTOPHANActive

Quantity: 90 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

ALANINEActive

Quantity: 1035 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

GLYCINEActive

Quantity: 515 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

ARGININEActive

Quantity: 575 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

PROLINEActive

Quantity: 340 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

SERINEActive

Quantity: 250 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

TYROSINEActive

Quantity: 20 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 340 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 59 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

DEXTROSEActive

Quantity: 20 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-7024

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateApril 13, 2021

FDA Product Classification

INGREDIENTS (25)

VALINEActive

Quantity: 247 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

GLYCINEActive

Quantity: 438 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

ARGININEActive

Quantity: 489 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

PROLINEActive

Quantity: 289 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

LEUCINEActive

Quantity: 311 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

PHENYLALANINEActive

Quantity: 238 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

LYSINEActive

Quantity: 247 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

METHIONINEActive

Quantity: 170 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

ISOLEUCINEActive

Quantity: 255 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

HISTIDINEActive

Quantity: 204 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

THREONINEActive

Quantity: 179 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

TRYPTOPHANActive

Quantity: 77 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

ALANINEActive

Quantity: 880 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

SERINEActive

Quantity: 213 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

TYROSINEActive

Quantity: 17 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 297 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 77 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

DEXTROSEActive

Quantity: 5 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-7030

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateApril 13, 2021

FDA Product Classification

INGREDIENTS (25)

LYSINEActive

Quantity: 290 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

METHIONINEActive

Quantity: 200 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

LEUCINEActive

Quantity: 365 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

PHENYLALANINEActive

Quantity: 280 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

ALANINEActive

Quantity: 1035 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

GLYCINEActive

Quantity: 515 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

ARGININEActive

Quantity: 575 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

VALINEActive

Quantity: 290 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

ISOLEUCINEActive

Quantity: 300 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

HISTIDINEActive

Quantity: 240 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

THREONINEActive

Quantity: 210 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

TRYPTOPHANActive

Quantity: 90 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

PROLINEActive

Quantity: 340 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

SERINEActive

Quantity: 250 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

TYROSINEActive

Quantity: 20 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 340 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 59 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

DEXTROSEActive

Quantity: 15 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-7026

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateApril 13, 2021

FDA Product Classification

INGREDIENTS (25)

TRYPTOPHANActive

Quantity: 77 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

ALANINEActive

Quantity: 880 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

LEUCINEActive

Quantity: 311 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

PHENYLALANINEActive

Quantity: 238 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

LYSINEActive

Quantity: 247 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

METHIONINEActive

Quantity: 170 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

ISOLEUCINEActive

Quantity: 255 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

VALINEActive

Quantity: 247 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

HISTIDINEActive

Quantity: 204 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

THREONINEActive

Quantity: 179 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

GLYCINEActive

Quantity: 438 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

ARGININEActive

Quantity: 489 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

PROLINEActive

Quantity: 289 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

SERINEActive

Quantity: 213 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

TYROSINEActive

Quantity: 17 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 297 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 77 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

DEXTROSEActive

Quantity: 10 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-7032

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateApril 13, 2021

FDA Product Classification

INGREDIENTS (25)

TRYPTOPHANActive

Quantity: 90 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

ALANINEActive

Quantity: 1035 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

GLYCINEActive

Quantity: 515 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

ARGININEActive

Quantity: 575 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

PROLINEActive

Quantity: 340 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

SERINEActive

Quantity: 250 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

TYROSINEActive

Quantity: 20 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 340 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

LEUCINEActive

Quantity: 365 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 59 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

DEXTROSEActive

Quantity: 15 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

PHENYLALANINEActive

Quantity: 280 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

LYSINEActive

Quantity: 290 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

METHIONINEActive

Quantity: 200 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

ISOLEUCINEActive

Quantity: 300 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

VALINEActive

Quantity: 290 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

HISTIDINEActive

Quantity: 240 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

THREONINEActive

Quantity: 210 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-7022

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateApril 13, 2021

FDA Product Classification

INGREDIENTS (25)

LEUCINEActive

Quantity: 311 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

PHENYLALANINEActive

Quantity: 238 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

LYSINEActive

Quantity: 247 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

METHIONINEActive

Quantity: 170 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

ISOLEUCINEActive

Quantity: 255 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

VALINEActive

Quantity: 247 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

HISTIDINEActive

Quantity: 204 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

THREONINEActive

Quantity: 179 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

TRYPTOPHANActive

Quantity: 77 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

ALANINEActive

Quantity: 880 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

GLYCINEActive

Quantity: 438 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

ARGININEActive

Quantity: 489 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 77 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

DEXTROSEActive

Quantity: 5 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CB

Classification: IACT

PROLINEActive

Quantity: 289 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

SERINEActive

Quantity: 213 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

TYROSINEActive

Quantity: 17 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 297 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0338-1125

Application NumberNDA020678

Product Classification

Marketing Category

C73594

Generic Name

Product Specifications

Route of AdministrationINTRAVENOUS

Effective DateSeptember 21, 2020

FDA Product Classification

INGREDIENTS (24)

LYSINEActive

Quantity: 290 mg in 100 mL

Code: K3Z4F929H6

Classification: ACTIB

THREONINEActive

Quantity: 210 mg in 100 mL

Code: 2ZD004190S

Classification: ACTIB

ISOLEUCINEActive

Quantity: 300 mg in 100 mL

Code: 04Y7590D77

Classification: ACTIB

HISTIDINEActive

Quantity: 240 mg in 100 mL

Code: 4QD397987E

Classification: ACTIB

ALANINEActive

Quantity: 1035 mg in 100 mL

Code: OF5P57N2ZX

Classification: ACTIB

TYROSINEActive

Quantity: 20 mg in 100 mL

Code: 42HK56048U

Classification: ACTIB

SODIUM ACETATEActive

Quantity: 340 mg in 100 mL

Code: 4550K0SC9B

Classification: ACTIB

PROLINEActive

Quantity: 340 mg in 100 mL

Code: 9DLQ4CIU6V

Classification: ACTIB

SERINEActive

Quantity: 250 mg in 100 mL

Code: 452VLY9402

Classification: ACTIB

DEXTROSEActive

Quantity: 20 g in 100 mL

Code: IY9XDZ35W2

Classification: ACTIB

CALCIUM CHLORIDEActive

Quantity: 33 mg in 100 mL

Code: M4I0D6VV5M

Classification: ACTIB

WATERInactive

Code: 059QF0KO0R

Classification: IACT

NITROGENInactive

Code: N762921K75

Classification: IACT

LEUCINEActive

Quantity: 365 mg in 100 mL

Code: GMW67QNF9C

Classification: ACTIB

PHENYLALANINEActive

Quantity: 280 mg in 100 mL

Code: 47E5O17Y3R

Classification: ACTIB

METHIONINEActive

Quantity: 200 mg in 100 mL

Code: AE28F7PNPL

Classification: ACTIB

VALINEActive

Quantity: 290 mg in 100 mL

Code: HG18B9YRS7

Classification: ACTIB

TRYPTOPHANActive

Quantity: 90 mg in 100 mL

Code: 8DUH1N11BX

Classification: ACTIB

GLYCINEActive

Quantity: 515 mg in 100 mL

Code: TE7660XO1C

Classification: ACTIB

ARGININEActive

Quantity: 575 mg in 100 mL

Code: 94ZLA3W45F

Classification: ACTIB

POTASSIUM PHOSPHATE, DIBASICActive

Quantity: 261 mg in 100 mL

Code: CI71S98N1Z

Classification: ACTIB

MAGNESIUM CHLORIDEActive

Quantity: 51 mg in 100 mL

Code: 02F3473H9O

Classification: ACTIB

SODIUM CHLORIDEActive

Quantity: 59 mg in 100 mL

Code: 451W47IQ8X

Classification: ACTIB

ACETIC ACIDInactive

Code: Q40Q9N063P

Classification: IACT

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Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

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INGREDIENTS (25)

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (25)

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (25)

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (25)

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (25)

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (25)

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (25)

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (25)

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (25)

Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose

Product Details

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Product Classification

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INGREDIENTS (24)

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