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United States· US:0990-7171_ea005122-3350-4609-83ad-9d093f25162f

Aminosyn II

A amino acids product containing isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine, registered in United States by ICU Medical Inc..

ATC B05XBOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAminosyn IIATCB05XBREGISTER NO.US:0990-7171_ea005122…PACKS LISTED1CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycineAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
Manufacturer
ICU Medical Inc.
Country
United States (US)
ATC code
B05XB
ATC class
Amino acids
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    0990717117
    6 POUCH in 1 CASE (0990-7171-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG

Regulatory notes

UNII (FDA substance ID)
DA8G610ZO5
ACETYL L-TYROSINE
RxCUI 31005
Orange Book
N020041
DailyMed SPL labels
1 version tracked

Same class

Other records under B05XB

Amino acids, as other registers publish it.

All isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/b94f7a9b-ccab-4467-a8e8-b9d1718b761d
GET /v1/drugs/b94f7a9b-ccab-4467-a8e8-b9d1718b761d?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "DA8G610ZO5",
    "rxcui": "31005",
    "inchikey": "CAHKINHBCWCHCF-JTQLQIEISA-N",
    "display_name": "ACETYL L-TYROSINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5b426208-f090-4650-86c3-89040ba45c2d": {
      "match": "brand_token",
      "title": "AMINOSYN II (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE) INJECTION, SOLUTION [ICU MEDICAL INC.]",
      "spl_version": "13",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0990-7171_ea005122-3350-4609-83ad-9d093f25162f",
  "productndc": "0990-7171",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020041",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15% (15GM/100ML)",
        "product_no": "001",
        "approval_date": "Dec 19, 1991"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETYL L-TYROSINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE",
  "proprietary_name": "Aminosyn II",
  "active_ingred_unit": "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",
  "application_number": "NDA020041",
  "marketing_category": "NDA",
  "nonproprietary_name": "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE",
  "start_marketing_date": "20191101",
  "active_numerator_strength": "405; 1490; 1527; 1050; 1107; 750; 450; 990; 1500; 1575; 258; 447; 1083; 795; 600; 300; 750"
}
API referenceMCP serverPlans

See everything about isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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