NDC 0264-9350

FreAmine HBC

Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, And Sodium Bisulfite

FreAmine HBC 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.

• Product ID: 0264-9350_29b04365-4f06-41d2-b2fd-af178695f83c
• NDC: 0264-9350
• Product Type: Human Prescription Drug
• Proprietary Name: FreAmine HBC
• Generic Name: Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, And Sodium Bisulfite
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1971-09-24
• Marketing Category: NDA / NDA
• Application Number: NDA016822
• 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
• 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
• Pharm Classes: Amino Acid [EPC],Amino Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0264-9350-55

6 CARTON in 1 CASE (0264-9350-55) > 1 CONTAINER in 1 CARTON > 750 mL in 1 CONTAINER

• Marketing Start Date: 1971-09-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0264-9350-55 [00264935055]

FreAmine HBC INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA016822
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1971-09-24

Drug Details

Active Ingredients

Ingredient	Strength
ISOLEUCINE	.76 g/100mL

OpenFDA Data

• SPL SET ID: 6ea7ec73-403e-4303-8862-6380e2f1fda6
• Manufacturer:
  • B. Braun Medical Inc.
• UNII:
  • OF5P57N2ZX
  • ZT934N0X4W
  • AE28F7PNPL
  • 2ZD004190S
  • 94ZLA3W45F
  • TTL6G7LIWZ
  • 47E5O17Y3R
  • 8DUH1N11BX
  • 9DLQ4CIU6V
  • 04Y7590D77
  • 4QD397987E
  • 452VLY9402
  • GMW67QNF9C
  • HG18B9YRS7
  • TE7660XO1C
• RxNorm Concept Unique ID - RxCUI:
  • 800858
  • 800862

Pharmacological Class

• Amino Acid [EPC]
• Amino Acids [CS]