NDC 0409-4178

Aminosyn-PF

Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine

Aminosyn-PF is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Isoleucine; Leucine; Lysine Acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Alanine; Arginine; Aspartic Acid; Glutamic Acid; Glycine; Histidine; Proline; Serine; Taurine; Tyrosine.

• Product ID: 0409-4178_3c3acf27-f71d-4d71-bc0c-7aeec534082b
• NDC: 0409-4178
• Product Type: Human Prescription Drug
• Proprietary Name: Aminosyn-PF
• Generic Name: Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1985-09-06
• Marketing Category: NDA / NDA
• Application Number: NDA019398
• Labeler Name: Hospira, Inc.
• Substance Name: ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; PROLINE; SERINE; TAURINE; TYROSINE
• Active Ingredient Strength: 534 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
• Pharm Classes: Amino Acid [EPC],Amino Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0409-4178-03

12 BAG in 1 CASE (0409-4178-03) > 500 mL in 1 BAG

• Marketing Start Date: 1985-09-06
• Marketing End Date: 2023-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-4178-03 [00409417803]

Aminosyn-PF INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019398
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1985-09-06

Drug Details

Active Ingredients

Ingredient	Strength
ISOLEUCINE	534 mg/100mL

OpenFDA Data

• SPL SET ID: ae5ae89b-2b93-4c88-f2bb-c554aeb8b12e
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • OF5P57N2ZX
  • 42HK56048U
  • AE28F7PNPL
  • 2ZD004190S
  • 94ZLA3W45F
  • TTL6G7LIWZ
  • 3KX376GY7L
  • 47E5O17Y3R
  • 1EQV5MLY3D
  • 8DUH1N11BX
  • 9DLQ4CIU6V
  • 04Y7590D77
  • 4QD397987E
  • 452VLY9402
  • GMW67QNF9C
  • HG18B9YRS7
  • 30KYC7MIAI
  • TE7660XO1C
• RxNorm Concept Unique ID - RxCUI:
  • 831426
  • 831430

Pharmacological Class

• Amino Acid [EPC]
• Amino Acids [CS]

NDC Crossover Matching brand name "Aminosyn-PF" or generic name "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Glycine, Histidine, Proline, Serine, Taurine, And Tyrosine"

NDC	Brand Name	Generic Name
0409-4178	Aminosyn-PF	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE
0409-4179	Aminosyn-PF	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE
0990-4178	Aminosyn-PF	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE
0990-4179	Aminosyn-PF	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE