NDC 0264-9371

HepatAmine

Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alani

HepatAmine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by B. Braun Medical Inc.. The primary component is Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Alanine; Arginine; Histidine; Proline; Serine; Glycine; Cysteine Hydrochloride; Phosphoric Acid.

• Product ID: 0264-9371_aea1ea70-a8f9-4f7e-abe5-d8ac880c5df7
• NDC: 0264-9371
• Product Type: Human Prescription Drug
• Proprietary Name: HepatAmine
• Generic Name: Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alani
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1982-08-03
• Marketing Category: NDA / NDA
• Application Number: NDA018676
• Labeler Name: B. Braun Medical Inc.
• Substance Name: ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; CYSTEINE HYDROCHLORIDE; PHOSPHORIC ACID
• Active Ingredient Strength: 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
• Pharm Classes: Amino Acid [EPC],Amino Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0264-9371-55

6 CARTON in 1 CASE (0264-9371-55) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER

• Marketing Start Date: 1982-08-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0264-9371-55 [00264937155]

HepatAmine INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA018676
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1982-08-03

Drug Details

Active Ingredients

Ingredient	Strength
ISOLEUCINE	.9 g/100mL

OpenFDA Data

• SPL SET ID: 2ec547bc-355c-42d4-a197-72e652c212de
• Manufacturer:
  • B. Braun Medical Inc.
• UNII:
  • OF5P57N2ZX
  • ZT934N0X4W
  • AE28F7PNPL
  • 2ZD004190S
  • 94ZLA3W45F
  • TTL6G7LIWZ
  • 47E5O17Y3R
  • 8DUH1N11BX
  • 9DLQ4CIU6V
  • 04Y7590D77
  • 4QD397987E
  • 452VLY9402
  • GMW67QNF9C
  • HG18B9YRS7
  • E4GA8884NN
  • TE7660XO1C
• RxNorm Concept Unique ID - RxCUI:
  • 800929
  • 800933

Pharmacological Class

• Amino Acid [EPC]
• Amino Acids [CS]

NDC Crossover Matching brand name "HepatAmine" or generic name "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alani"

NDC	Brand Name	Generic Name
0264-9371	HepatAmine	isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alani
0409-4168	Aminosyn	Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alani
0409-4187	Aminosyn	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
0409-4191	Aminosyn	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
0409-4196	Aminosyn	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
0409-4200	Aminosyn	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
0409-4203	Aminosyn	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
0409-4162	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
0409-4164	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
0409-7121	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
0409-4192	Aminosyn Sulfite Free	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI