NDC 0338-1131

Premasol - sulfite-free (Amino Acid)

Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride

Premasol - sulfite-free (Amino Acid) is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Leucine; Lysine Acetate; Isoleucine; Valine; Histidine; Phenylalanine; Threonine; Methionine; Tryptophan; Tyrosine; Arginine; Proline; Alanine; Glutamic Acid; Serine; Glycine; Aspartic Acid; Taurine; Cysteine Hydrochloride.

• Product ID: 0338-1131_49eb2f11-79ad-47ec-8c8f-7ebbf0490285
• NDC: 0338-1131
• Product Type: Human Prescription Drug
• Proprietary Name: Premasol - sulfite-free (Amino Acid)
• Generic Name: Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2003-06-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075880
• Labeler Name: Baxter Healthcare Corporation
• Substance Name: LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; 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; g/100mL; g/100mL; mg/100mL; g/100mL
• Pharm Classes: Amino Acid [EPC],Amino Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0338-1131-03

500 mL in 1 BAG (0338-1131-03)

• Marketing Start Date: 2003-06-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0338-1131-03 [00338113103]

Premasol - sulfite-free (Amino Acid) INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075880
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2003-06-19

Drug Details

Active Ingredients

Ingredient	Strength
LEUCINE	.84 g/100mL

OpenFDA Data

• SPL SET ID: 9afdcc3e-0d06-47f4-86ca-40da48b2b02b
• Manufacturer:
  • Baxter Healthcare Corporation
• UNII:
  • OF5P57N2ZX
  • 42HK56048U
  • 4QD397987E
  • TE7660XO1C
  • 2ZD004190S
  • 1EQV5MLY3D
  • 94ZLA3W45F
  • TTL6G7LIWZ
  • 3KX376GY7L
  • 47E5O17Y3R
  • 8DUH1N11BX
  • ZT934N0X4W
  • 04Y7590D77
  • 452VLY9402
  • GMW67QNF9C
  • HG18B9YRS7
  • 9DLQ4CIU6V
  • 30KYC7MIAI
  • AE28F7PNPL
• RxNorm Concept Unique ID - RxCUI:
  • 801395
  • 801403
  • 801405
  • 801398

Pharmacological Class

• Amino Acid [EPC]
• Amino Acids [CS]

NDC Crossover Matching brand name "Premasol - sulfite-free (Amino Acid)" or generic name "Leucine, Lysine, Isoleucine, Valine, Histidine, Phenylalanine, Threonine, Methionine, Tryptophan, Tyrosine, N-acetyl-tyrosine, Arginine, Proline, Alanine, Glutamic Acide, Serine, Glycine, Aspartic Acid, Taurine, Cysteine Hydrochloride"

NDC	Brand Name	Generic Name
0338-1130	Premasol - sulfite-free (Amino Acid)	LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE
0338-1131	Premasol - sulfite-free (Amino Acid)	LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE