CLINIMIX

Basic Information

Product Name

CLINIMIX

FDA Product Code

0338-1134

Regulatory Information

NDC Product Code

0338-1134

Application Number

NDA020734

Marketing Category

C73594

Effective Date

April 13, 2021

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LEUCINE

Quantity: 311 mg in 100 mL

Code: GMW67QNF9C

Class Code: ACTIB

PHENYLALANINE

Quantity: 238 mg in 100 mL

Code: 47E5O17Y3R

Class Code: ACTIB

HISTIDINE

Quantity: 204 mg in 100 mL

Code: 4QD397987E

Class Code: ACTIB

THREONINE

Quantity: 179 mg in 100 mL

Code: 2ZD004190S

Class Code: ACTIB

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

NITROGEN

Code: N762921K75

Class Code: IACT

LYSINE

Quantity: 247 mg in 100 mL

Code: K3Z4F929H6

Class Code: ACTIB

TRYPTOPHAN

Quantity: 77 mg in 100 mL

Code: 8DUH1N11BX

Class Code: ACTIB

ALANINE

Quantity: 880 mg in 100 mL

Code: OF5P57N2ZX

Class Code: ACTIB

GLYCINE

Quantity: 438 mg in 100 mL

Code: TE7660XO1C

Class Code: ACTIB

ARGININE

Quantity: 489 mg in 100 mL

Code: 94ZLA3W45F

Class Code: ACTIB

PROLINE

Quantity: 289 mg in 100 mL

Code: 9DLQ4CIU6V

Class Code: ACTIB

SERINE

Quantity: 213 mg in 100 mL

Code: 452VLY9402

Class Code: ACTIB

TYROSINE

Quantity: 17 mg in 100 mL

Code: 42HK56048U

Class Code: ACTIB

DEXTROSE

Quantity: 10 g in 100 mL

Code: IY9XDZ35W2

Class Code: ACTIB

METHIONINE

Quantity: 170 mg in 100 mL

Code: AE28F7PNPL

Class Code: ACTIB

ISOLEUCINE

Quantity: 255 mg in 100 mL

Code: 04Y7590D77

Class Code: ACTIB

VALINE

Quantity: 247 mg in 100 mL

Code: HG18B9YRS7

Class Code: ACTIB

Active Moieties

ISOLEUCINE

Code: 04Y7590D77

PHENYLALANINE

Code: 47E5O17Y3R

LYSINE

Code: K3Z4F929H6

METHIONINE

Code: AE28F7PNPL

LEUCINE

Code: GMW67QNF9C

VALINE

Code: HG18B9YRS7

HISTIDINE

Code: 4QD397987E

THREONINE

Code: 2ZD004190S

ARGININE

Code: 94ZLA3W45F

TYROSINE

Code: 42HK56048U

TRYPTOPHAN

Code: 8DUH1N11BX

SERINE

Code: 452VLY9402

ALANINE

Code: OF5P57N2ZX

GLYCINE

Code: TE7660XO1C

PROLINE

Code: 9DLQ4CIU6V

DEXTROSE

Code: IY9XDZ35W2

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

Basic Information

Regulatory Information

Company Information

Active Ingredients

ACETIC ACID

WATER

NITROGEN

Active Moieties

ISOLEUCINE

PHENYLALANINE

LYSINE

METHIONINE

LEUCINE

VALINE

HISTIDINE

THREONINE

ARGININE

TYROSINE

TRYPTOPHAN

SERINE

ALANINE

GLYCINE

PROLINE

DEXTROSE

ANHYDROUS DEXTROSE