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United States · US · US:0338-0499_ee240b46-c2a9-42e0-8750-a5a554becea3

ProSol

Orange BookUNIISPLATC B05XB

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeB05XB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0338049906
    2000 mL in 1 BAG (0338-0499-06)

Annotations

UNII (FDA Substance ID)
OF5P57N2ZX
ALANINE
RxCUI 426
Orange Book
N020849
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": {
    "cc2ace81-5881-43f1-ba94-41b674adc2fc": {
      "match": "brand_token",
      "title": "PROSOL (VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "14",
      "published_date": "2025-01-13"
    }
  },
  "productid": "0338-0499_ee240b46-c2a9-42e0-8750-a5a554becea3",
  "productndc": "0338-0499",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020849",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20% (20GM/100ML)",
        "product_no": "001",
        "approval_date": "Aug 26, 1998"
      }
    ],
    "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; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
  "proprietary_name": "ProSol",
  "active_ingred_unit": "g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
  "application_number": "NDA020849",
  "marketing_category": "NDA",
  "nonproprietary_name": "Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine",
  "start_marketing_date": "19980826",
  "active_numerator_strength": "2.76; 1.96; 600; 1.02; 2.06; 1.18; 1.08; 1.08; 1.35; 760; 1; 1.34; 1.02; 980; 320; 50; 1.44"
}

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