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0409-4178 NDC - AMINOSYN-PF (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE)

Drug Information

Product NDC: 0409-4178

Proprietary Name: Aminosyn-PF

Non Proprietary Name: ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE

Active Ingredient(s):
  • 490 mg/100mL ALANINE;
  • 861 mg/100mL ARGININE;
  • 370 mg/100mL ASPARTIC ACID;
  • 576 mg/100mL GLUTAMIC ACID;
  • 270 mg/100mL GLYCINE;
  • 220 mg/100mL HISTIDINE;
  • 534 mg/100mL ISOLEUCINE;
  • 831 mg/100mL LEUCINE;
  • 475 mg/100mL LYSINE ACETATE;
  • 125 mg/100mL METHIONINE;
  • 300 mg/100mL PHENYLALANINE;
  • 570 mg/100mL PROLINE;
  • 347 mg/100mL SERINE;
  • 50 mg/100mL TAURINE;
  • 360 mg/100mL THREONINE;
  • 125 mg/100mL TRYPTOPHAN;
  • 44 mg/100mL TYROSINE;
  • 452 mg/100mL VALINE


Administration Route(s): INTRAVENOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Amino Acid [EPC];
  • Amino Acids [CS]

Labeler Information

Labeler Name: Hospira, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA019398
Marketing Category: NDA
Start Marketing Date:9/6/1985
End Marketing Date:12/1/2023

Package Information

No. Package Code Package Description Billing Unit
10409-4178-0312 BAG in 1 CASE (0409-4178-03) > 500 mL in 1 BAGML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0409-4178The 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 NAMEAminosyn-PFThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINEThe 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 DATE9/6/1985This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE12/1/2023This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA019398This 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 NAMEHospira, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALANINE; ARGININE; ASPARTIC ACID; 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 STRENGTH490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452 
ACTIVE INGRED UNITmg/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 CLASSESAmino Acid [EPC], Amino Acids [CS] 

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This page was last updated on: 11/10/2022