NDC 0409-4162

Aminosyn II

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

Aminosyn II is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Isoleucine; Leu.

• Product ID: 0409-4162_035eb1a0-d767-4dbf-8f4a-6ea72f9a3cb5
• NDC: 0409-4162
• Product Type: Human Prescription Drug
• Proprietary Name: Aminosyn II
• Generic Name: Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alani
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2005-07-29
• Marketing Category: NDA / NDA
• Application Number: NDA019438
• Labeler Name: Hospira, Inc.
• Substance Name: ISOLEUCINE; LEU
• Active Ingredient Strength: 561 mg/100mL; mg/10
• Pharm Classes: Amino Acid [EPC
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 0409-4162-03

12 POUCH in 1 CASE (0409-4162-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

• Marketing Start Date: 2006-05-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-4162-03 [00409416203]

Aminosyn II INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019438
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-05-09
• Marketing End Date: 2017-06-01

NDC 0409-4162-05 [00409416205]

Aminosyn II INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA019438
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-07-29
• Marketing End Date: 2011-04-01

Drug Details

Active Ingredients

Ingredient	Strength
ISOLEUCINE	561 mg/100mL

OpenFDA Data

• SPL SET ID: 517d10ba-08ce-4410-d594-5618a48866c9
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • OF5P57N2ZX
  • 4QD397987E
  • TE7660XO1C
  • 94ZLA3W45F
  • 2ZD004190S
  • TTL6G7LIWZ
  • 3KX376GY7L
  • 47E5O17Y3R
  • 8DUH1N11BX
  • DA8G610ZO5
  • 04Y7590D77
  • 452VLY9402
  • GMW67QNF9C
  • HG18B9YRS7
  • 9DLQ4CIU6V
  • 30KYC7MIAI
  • AE28F7PNPL
• RxNorm Concept Unique ID - RxCUI:
  • 800220
  • 800209
  • 800237
  • 800213
  • 800216
  • 800241

Pharmacological Class

• Amino Acid [EPC]
• Amino Acids [CS]

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

NDC	Brand Name	Generic Name
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
0409-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
0409-7172	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
0990-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
0990-7172	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
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
0409-4192	Aminosyn Sulfite Free	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
0264-9371	HepatAmine	isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alani