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United States · US · US:0990-4178_488d78ac-3cd2-4593-8968-2992fe59bb49

Aminosyn-PF

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
    0990417803
    12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
OF5P57N2ZX
ALANINE
RxCUI 426
Orange Book
N019398
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "OF5P57N2ZX",
    "rxcui": "426",
    "inchikey": "QNAYBMKLOCPYGJ-REOHCLBHSA-N",
    "display_name": "ALANINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "46e74ce4-cd7e-437f-bf54-ca9b98eb2663": {
      "match": "brand_token",
      "title": "AMINOSYN-PF (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE) INJECTION, SOLUTION [ICU MEDICAL INC.]",
      "spl_version": "12",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0990-4178_488d78ac-3cd2-4593-8968-2992fe59bb49",
  "productndc": "0990-4178",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019398",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "7% (7GM/100ML)",
        "product_no": "001",
        "approval_date": "Sep 6, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
  "proprietary_name": "Aminosyn-PF",
  "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; mg/100mL",
  "application_number": "NDA019398",
  "marketing_category": "NDA",
  "nonproprietary_name": "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE",
  "start_marketing_date": "20211001",
  "active_numerator_strength": "490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452"
}

Related drugs

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