0338-1130 NDC - 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)

Drug Information

  • Product NDC: 0338-1130
  • Proprietary Name: Premasol - sulfite-free (Amino Acid)
  • Non Proprietary 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
  • Active Ingredient(s): .54 g/100mL ALANINE; 1.2 g/100mL ARGININE; .32 g/100mL ASPARTIC ACID; .016 g/100mL CYSTEINE HYDROCHLORIDE; .5 g/100mL GLUTAMIC ACID; .36 g/100mL GLYCINE; .48 g/100mL HISTIDINE; .82 g/100mL ISOLEUCINE; 1.4 g/100mL LEUCINE; .82 g/100mL LYSINE ACETATE; .34 g/100mL METHIONINE; .48 g/100mL PHENYLALANINE; .68 g/100mL PROLINE; .38 g/100mL SERINE; 25 mg/100mL TAURINE; .42 g/100mL THREONINE; .2 g/100mL TRYPTOPHAN; .24 g/100mL TYROSINE; .78 g/100mL VALINE
  • Administration Route(s): INTRAVENOUS
  • Dosage Form(s): INJECTION, SOLUTION
  • Pharmacy Class(es): Amino Acid [EPC]; Amino Acids [CS]

Labeler Information

Field Name Field Value
Labeler Name: Baxter Healthcare Company
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA075880
Marketing Category: ANDA
Start Marketing Date:6/19/2003

Package Information

No. Package Code Package Description Billing Unit
10338-1130-03500 mL in 1 BAG (0338-1130-03)ML
20338-1130-041000 mL in 1 BAG (0338-1130-04)ML
30338-1130-062000 mL in 1 BAG (0338-1130-06)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0338-1130The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEPremasol - sulfite-free (Amino Acid)The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/19/2003This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA075880This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEBaxter Healthcare CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.54; 1.2; .32; .016; .5; .36; .48; .82; 1.4; .82; .34; .48; .68; .38; 25; .42; .2; .24; .78 
ACTIVE INGRED UNITg/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; g/100mL; g/100mL; g/100mL 
PHARM CLASSESAmino Acid [EPC], Amino Acids [CS] 

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This page was last updated on: 7/25/2025

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