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United States · US · US:0990-4179_2d8f2280-bc20-45ba-bdf3-12c055684017

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
    0990417905
    6 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
OF5P57N2ZX
ALANINE
RxCUI 426
Orange Book
N019492
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": "0990-4179_2d8f2280-bc20-45ba-bdf3-12c055684017",
  "productndc": "0990-4179",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019492",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10% (10GM/100ML)",
        "product_no": "002",
        "approval_date": "Oct 17, 1986"
      }
    ],
    "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": "NDA019492",
  "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": "20191101",
  "active_numerator_strength": "698; 1227; 527; 820; 385; 312; 760; 1200; 677; 180; 427; 812; 495; 70; 512; 180; 44; 673"
}

Related drugs

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