NDC 0990-7172 Aminosyn Ii

Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine

NDC Product Code 0990-7172

NDC Product Information

Aminosyn Ii with NDC 0990-7172 is a a human prescription drug product labeled by Icu Medical Inc.. The generic name of Aminosyn Ii is isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: Icu Medical Inc.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates 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.

Aminosyn Ii Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ISOLEUCINE 660 mg/100mL
  • LEUCINE 1000 mg/100mL
  • LYSINE ACETATE 1050 mg/100mL
  • METHIONINE 172 mg/100mL
  • PHENYLALANINE 298 mg/100mL
  • THREONINE 400 mg/100mL
  • TRYPTOPHAN 200 mg/100mL
  • VALINE 500 mg/100mL
  • ALANINE 993 mg/100mL
  • ARGININE 1018 mg/100mL
  • ASPARTIC ACID 700 mg/100mL
  • GLUTAMIC ACID 738 mg/100mL
  • HISTIDINE 300 mg/100mL
  • PROLINE 722 mg/100mL
  • SERINE 530 mg/100mL
  • N-ACETYLTYROSINE 270 mg/100mL
  • GLYCINE 500 mg/100mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Amino Acid - [EPC] (Established Pharmacologic Class)
  • Amino Acids - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Icu Medical Inc.
Labeler Code: 0990
FDA Application Number: NDA020015 What is the FDA Application Number?
This 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product 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.

Start Marketing Date: 11-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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