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United States · US · US:0990-7172_ea005122-3350-4609-83ad-9d093f25162f

Aminosyn II

Orange BookUNIISPLATC B05XB

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerICU Medical Inc.
CountryUS (United States)
ATC codeB05XB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0990717217
    6 POUCH in 1 CASE (0990-7172-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
DA8G610ZO5
ACETYL L-TYROSINE
RxCUI 31005
Orange Book
N020015
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "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": "0990-7172_ea005122-3350-4609-83ad-9d093f25162f",
  "productndc": "0990-7172",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020015",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10% (10GM/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": "NDA020015",
  "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": "270; 993; 1018; 700; 738; 500; 300; 660; 1000; 1050; 172; 298; 722; 530; 400; 200; 500"
}

Related drugs

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