NDC 0264-1909

NephrAmine

Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine, And Sodium Bisulfite

NephrAmine 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 Histidine; Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Cysteine Hydrochloride.

• Product ID: 0264-1909_1ce47977-a86a-4359-8277-1c6bd81eb0d9
• NDC: 0264-1909
• Product Type: Human Prescription Drug
• Proprietary Name: NephrAmine
• Generic Name: Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine, And Sodium Bisulfite
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1978-02-24
• Marketing Category: NDA / NDA
• Application Number: NDA017766
• Labeler Name: B. Braun Medical Inc.
• Substance Name: HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CYSTEINE HYDROCHLORIDE
• Active Ingredient Strength: 0 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0264-1909-55

12 CARTON in 1 CASE (0264-1909-55) > 1 CONTAINER in 1 CARTON > 250 mL in 1 CONTAINER

• Marketing Start Date: 1978-02-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0264-1909-55 [00264190955]

NephrAmine INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017766
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1978-02-24

Drug Details

Active Ingredients

Ingredient	Strength
HISTIDINE	.25 g/100mL

OpenFDA Data

• SPL SET ID: b924dbf2-5400-4036-941e-487d2ddbb5c4
• Manufacturer:
  • B. Braun Medical Inc.
• UNII:
  • AE28F7PNPL
  • 2ZD004190S
  • TTL6G7LIWZ
  • 47E5O17Y3R
  • 8DUH1N11BX
  • ZT934N0X4W
  • 04Y7590D77
  • 4QD397987E
  • GMW67QNF9C
  • HG18B9YRS7
• RxNorm Concept Unique ID - RxCUI:
  • 800979
  • 800976