Aminosyn II
Aminosyn II
Approved
Approval ID
5b426208-f090-4650-86c3-89040ba45c2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 4, 2022
Manufacturers
FDA
ICU Medical Inc.
DUNS: 118380146
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7172
Application NumberNDA020015
Product Classification
M
Marketing Category
C73594
G
Generic Name
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 4, 2022
FDA Product Classification
INGREDIENTS (18)
LEUCINEActive
Quantity: 1000 mg in 100 mL
Code: GMW67QNF9C
Classification: ACTIB
METHIONINEActive
Quantity: 172 mg in 100 mL
Code: AE28F7PNPL
Classification: ACTIB
PHENYLALANINEActive
Quantity: 298 mg in 100 mL
Code: 47E5O17Y3R
Classification: ACTIB
THREONINEActive
Quantity: 400 mg in 100 mL
Code: 2ZD004190S
Classification: ACTIB
TRYPTOPHANActive
Quantity: 200 mg in 100 mL
Code: 8DUH1N11BX
Classification: ACTIB
ALANINEActive
Quantity: 993 mg in 100 mL
Code: OF5P57N2ZX
Classification: ACTIB
ARGININEActive
Quantity: 1018 mg in 100 mL
Code: 94ZLA3W45F
Classification: ACTIB
ASPARTIC ACIDActive
Quantity: 700 mg in 100 mL
Code: 30KYC7MIAI
Classification: ACTIB
GLUTAMIC ACIDActive
Quantity: 738 mg in 100 mL
Code: 3KX376GY7L
Classification: ACTIB
ACETYL L-TYROSINEActive
Quantity: 270 mg in 100 mL
Code: DA8G610ZO5
Classification: ACTIB
SERINEActive
Quantity: 530 mg in 100 mL
Code: 452VLY9402
Classification: ACTIB
LYSINE ACETATEActive
Quantity: 1050 mg in 100 mL
Code: TTL6G7LIWZ
Classification: ACTIM
VALINEActive
Quantity: 500 mg in 100 mL
Code: HG18B9YRS7
Classification: ACTIB
HISTIDINEActive
Quantity: 300 mg in 100 mL
Code: 4QD397987E
Classification: ACTIB
PROLINEActive
Quantity: 722 mg in 100 mL
Code: 9DLQ4CIU6V
Classification: ACTIB
ISOLEUCINEActive
Quantity: 660 mg in 100 mL
Code: 04Y7590D77
Classification: ACTIB
GLYCINEActive
Quantity: 500 mg in 100 mL
Code: TE7660XO1C
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7171
Application NumberNDA020041
Product Classification
M
Marketing Category
C73594
G
Generic Name
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 4, 2022
FDA Product Classification
INGREDIENTS (18)
LYSINE ACETATEActive
Quantity: 1575 mg in 100 mL
Code: TTL6G7LIWZ
Classification: ACTIM
VALINEActive
Quantity: 750 mg in 100 mL
Code: HG18B9YRS7
Classification: ACTIB
ARGININEActive
Quantity: 1527 mg in 100 mL
Code: 94ZLA3W45F
Classification: ACTIB
ACETYL L-TYROSINEActive
Quantity: 405 mg in 100 mL
Code: DA8G610ZO5
Classification: ACTIB
ISOLEUCINEActive
Quantity: 990 mg in 100 mL
Code: 04Y7590D77
Classification: ACTIB
LEUCINEActive
Quantity: 1500 mg in 100 mL
Code: GMW67QNF9C
Classification: ACTIB
METHIONINEActive
Quantity: 258 mg in 100 mL
Code: AE28F7PNPL
Classification: ACTIB
PHENYLALANINEActive
Quantity: 447 mg in 100 mL
Code: 47E5O17Y3R
Classification: ACTIB
THREONINEActive
Quantity: 600 mg in 100 mL
Code: 2ZD004190S
Classification: ACTIB
TRYPTOPHANActive
Quantity: 300 mg in 100 mL
Code: 8DUH1N11BX
Classification: ACTIB
ALANINEActive
Quantity: 1490 mg in 100 mL
Code: OF5P57N2ZX
Classification: ACTIB
ASPARTIC ACIDActive
Quantity: 1050 mg in 100 mL
Code: 30KYC7MIAI
Classification: ACTIB
GLUTAMIC ACIDActive
Quantity: 1107 mg in 100 mL
Code: 3KX376GY7L
Classification: ACTIB
HISTIDINEActive
Quantity: 450 mg in 100 mL
Code: 4QD397987E
Classification: ACTIB
PROLINEActive
Quantity: 1083 mg in 100 mL
Code: 9DLQ4CIU6V
Classification: ACTIB
SERINEActive
Quantity: 795 mg in 100 mL
Code: 452VLY9402
Classification: ACTIB
GLYCINEActive
Quantity: 750 mg in 100 mL
Code: TE7660XO1C
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT