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United States · US · US:0338-0644_e0279078-016d-48fd-8de1-c894422b33ff

Travasol

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 · 3

  • ndc11
    0338064403
    500 mL in 1 BAG (0338-0644-03)
  • ndc11
    0338064404
    1000 mL in 1 BAG (0338-0644-04)
  • ndc11
    0338064406
    2000 mL in 1 BAG (0338-0644-06)

Annotations

UNII (FDA Substance ID)
OF5P57N2ZX
ALANINE
RxCUI 426
Orange Book
N018931
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": {
    "8543b5be-0f43-4891-9e56-d7c39fe839b5": {
      "match": "brand_token",
      "title": "TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE) INJECTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "16",
      "published_date": "2025-02-10"
    }
  },
  "productid": "0338-0644_e0279078-016d-48fd-8de1-c894422b33ff",
  "productndc": "0338-0644",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "018931",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5.5% (5.5GM/100ML)",
        "product_no": "001",
        "approval_date": "Aug 23, 1984"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "8.5% (8.5GM/100ML)",
        "product_no": "002",
        "approval_date": "Aug 23, 1984"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10% (10MG/100ML)",
        "product_no": "003",
        "approval_date": "Aug 23, 1984"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
  "proprietary_name": "Travasol",
  "active_ingred_unit": "g/100mL; g/100mL; g/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": "NDA018931",
  "marketing_category": "NDA",
  "nonproprietary_name": "Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
  "start_marketing_date": "19840823",
  "active_numerator_strength": "2.07; 1.15; 1.03; 480; 600; 730; 580; 400; 560; 680; 500; 420; 180; 40; 580"
}

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