0990-4179 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: 0990-4179

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):
  • 698 mg/100mL ALANINE;
  • 1227 mg/100mL ARGININE;
  • 527 mg/100mL ASPARTIC ACID;
  • 820 mg/100mL GLUTAMIC ACID;
  • 385 mg/100mL GLYCINE;
  • 312 mg/100mL HISTIDINE;
  • 760 mg/100mL ISOLEUCINE;
  • 1200 mg/100mL LEUCINE;
  • 677 mg/100mL LYSINE ACETATE;
  • 180 mg/100mL METHIONINE;
  • 427 mg/100mL PHENYLALANINE;
  • 812 mg/100mL PROLINE;
  • 495 mg/100mL SERINE;
  • 70 mg/100mL TAURINE;
  • 512 mg/100mL THREONINE;
  • 180 mg/100mL TRYPTOPHAN;
  • 44 mg/100mL TYROSINE;
  • 673 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: ICU Medical Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA019492
Marketing Category: NDA
Start Marketing Date:11/1/2019

Package Information

No. Package Code Package Description Billing Unit
10990-4179-056 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAGML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0990-4179The 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 DATE11/1/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NUMBERNDA019492This 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 NAMEICU Medical 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 STRENGTH698; 1227; 527; 820; 385; 312; 760; 1200; 677; 180; 427; 812; 495; 70; 512; 180; 44; 673 
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: 2/1/2023