Plenamine
Plenamine™15% Amino Acids Injection
Approved
Approval ID
a3244d1a-45b0-4e4c-bd96-f0632d761a1f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2023
Manufacturers
FDA
B. Braun Medical Inc.
DUNS: 002397347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE
PRODUCT DETAILS
NDC Product Code0264-4500
Application NumberANDA091112
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateApril 21, 2023
Generic NameLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE
INGREDIENTS (19)
LEUCINEActive
Quantity: 1.04 g in 100 mL
Code: GMW67QNF9C
Classification: ACTIB
LYSINE ACETATEActive
Quantity: 1.18 g in 100 mL
Code: TTL6G7LIWZ
Classification: ACTIM
VALINEActive
Quantity: 960 mg in 100 mL
Code: HG18B9YRS7
Classification: ACTIB
METHIONINEActive
Quantity: 749 mg in 100 mL
Code: AE28F7PNPL
Classification: ACTIB
TRYPTOPHANActive
Quantity: 250 mg in 100 mL
Code: 8DUH1N11BX
Classification: ACTIB
ARGININEActive
Quantity: 1.47 g in 100 mL
Code: 94ZLA3W45F
Classification: ACTIB
THREONINEActive
Quantity: 749 mg in 100 mL
Code: 2ZD004190S
Classification: ACTIB
GLYCINEActive
Quantity: 1.04 g in 100 mL
Code: TE7660XO1C
Classification: ACTIB
PROLINEActive
Quantity: 894 mg in 100 mL
Code: 9DLQ4CIU6V
Classification: ACTIB
GLUTAMIC ACIDActive
Quantity: 749 mg in 100 mL
Code: 3KX376GY7L
Classification: ACTIB
SERINEActive
Quantity: 592 mg in 100 mL
Code: 452VLY9402
Classification: ACTIB
ASPARTIC ACIDActive
Quantity: 434 mg in 100 mL
Code: 30KYC7MIAI
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HISTIDINEActive
Quantity: 894 mg in 100 mL
Code: 4QD397987E
Classification: ACTIB
TYROSINEActive
Quantity: 39 mg in 100 mL
Code: 42HK56048U
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
PHENYLALANINEActive
Quantity: 1.04 g in 100 mL
Code: 47E5O17Y3R
Classification: ACTIB
ISOLEUCINEActive
Quantity: 749 mg in 100 mL
Code: 04Y7590D77
Classification: ACTIB
ALANINEActive
Quantity: 2.17 g in 100 mL
Code: OF5P57N2ZX
Classification: ACTIB