Search Icon

0409-7171 NDC - AMINOSYN II (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE)

Drug Information

Product NDC: 0409-7171

Proprietary Name: Aminosyn II

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

Active Ingredient(s):
  • 1490 mg/100mL ALANINE;
  • 1527 mg/100mL ARGININE;
  • 1050 mg/100mL ASPARTIC ACID;
  • 1107 mg/100mL GLUTAMIC ACID;
  • 750 mg/100mL GLYCINE;
  • 450 mg/100mL HISTIDINE;
  • 990 mg/100mL ISOLEUCINE;
  • 1500 mg/100mL LEUCINE;
  • 1575 mg/100mL LYSINE ACETATE;
  • 258 mg/100mL METHIONINE;
  • 405 mg/100mL N-ACETYLTYROSINE;
  • 447 mg/100mL PHENYLALANINE;
  • 1083 mg/100mL PROLINE;
  • 795 mg/100mL SERINE;
  • 600 mg/100mL THREONINE;
  • 300 mg/100mL TRYPTOPHAN;
  • 750 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: NDA020041
Marketing Category: NDA
Start Marketing Date:12/19/1991
End Marketing Date:12/1/2023

Package Information

No. Package Code Package Description Billing Unit
10409-7171-176 POUCH in 1 CASE (0409-7171-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAGML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0409-7171The 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 IIThe 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, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINEThe 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 DATE12/19/1991This 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 NUMBERNDA020041This 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; N-ACETYLTYROSINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; 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 STRENGTH1490; 1527; 1050; 1107; 750; 450; 990; 1500; 1575; 258; 405; 447; 1083; 795; 600; 300; 750 
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 
PHARM CLASSESAmino Acid [EPC], Amino Acids [CS] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 2/1/2023