NDC 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

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 ID0338-1130_49eb2f11-79ad-47ec-8c8f-7ebbf0490285
NDC0338-1130
Product TypeHuman Prescription Drug
Proprietary NamePremasol - sulfite-free (Amino Acid)
Generic NameLeucine, 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 FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2003-06-19
Marketing CategoryANDA / ANDA
Application NumberANDA075880
Labeler NameBaxter Healthcare Corporation
Substance NameLEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE
Active Ingredient Strength1 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 ClassesAmino Acid [EPC],Amino Acids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0338-1130-03

500 mL in 1 BAG (0338-1130-03)
Marketing Start Date2003-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0338-1130-06 [00338113006]

Premasol - sulfite-free (Amino Acid) INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075880
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-06-19

NDC 0338-1130-03 [00338113003]

Premasol - sulfite-free (Amino Acid) INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075880
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-06-19

NDC 0338-1130-04 [00338113004]

Premasol - sulfite-free (Amino Acid) INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA075880
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-06-19

Drug Details

Active Ingredients

IngredientStrength
LEUCINE1.4 g/100mL

OpenFDA Data

SPL SET ID:9afdcc3e-0d06-47f4-86ca-40da48b2b02b
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0338-1130Premasol - 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
    0338-1131Premasol - 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

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