Aminosyn-PF
Aminosyn -PF 10%Sulfite-Free
Approved
Approval ID
46e74ce4-cd7e-437f-bf54-ca9b98eb2663
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2022
Manufacturers
FDA
ICU Medical Inc.
DUNS: 118380146
Products 1
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, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-4179
Application NumberNDA019492
Product Classification
M
Marketing Category
C73594
G
Generic Name
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 19, 2022
FDA Product Classification
INGREDIENTS (19)
LEUCINEActive
Quantity: 1200 mg in 100 mL
Code: GMW67QNF9C
Classification: ACTIB
LYSINE ACETATEActive
Quantity: 677 mg in 100 mL
Code: TTL6G7LIWZ
Classification: ACTIM
METHIONINEActive
Quantity: 180 mg in 100 mL
Code: AE28F7PNPL
Classification: ACTIB
PHENYLALANINEActive
Quantity: 427 mg in 100 mL
Code: 47E5O17Y3R
Classification: ACTIB
THREONINEActive
Quantity: 512 mg in 100 mL
Code: 2ZD004190S
Classification: ACTIB
TRYPTOPHANActive
Quantity: 180 mg in 100 mL
Code: 8DUH1N11BX
Classification: ACTIB
ISOLEUCINEActive
Quantity: 760 mg in 100 mL
Code: 04Y7590D77
Classification: ACTIB
VALINEActive
Quantity: 673 mg in 100 mL
Code: HG18B9YRS7
Classification: ACTIB
ALANINEActive
Quantity: 698 mg in 100 mL
Code: OF5P57N2ZX
Classification: ACTIB
ARGININEActive
Quantity: 1227 mg in 100 mL
Code: 94ZLA3W45F
Classification: ACTIB
ASPARTIC ACIDActive
Quantity: 527 mg in 100 mL
Code: 30KYC7MIAI
Classification: ACTIB
GLUTAMIC ACIDActive
Quantity: 820 mg in 100 mL
Code: 3KX376GY7L
Classification: ACTIB
GLYCINEActive
Quantity: 385 mg in 100 mL
Code: TE7660XO1C
Classification: ACTIB
HISTIDINEActive
Quantity: 312 mg in 100 mL
Code: 4QD397987E
Classification: ACTIB
PROLINEActive
Quantity: 812 mg in 100 mL
Code: 9DLQ4CIU6V
Classification: ACTIB
SERINEActive
Quantity: 495 mg in 100 mL
Code: 452VLY9402
Classification: ACTIB
TAURINEActive
Quantity: 70 mg in 100 mL
Code: 1EQV5MLY3D
Classification: ACTIB
TYROSINEActive
Quantity: 44 mg in 100 mL
Code: 42HK56048U
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT