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United States · US · US:0338-3993_fdee89dd-171b-4c31-9651-919cd8aaff39

IFEX

Orange BookUNIISPLATC L01AA06

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeL01AA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0338399301
    1 VIAL, SINGLE-DOSE in 1 CARTON (0338-3993-01) / 60 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
UM20QQM95Y
IFOSFAMIDE
RxCUI 5657
Orange Book
N019763
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "UM20QQM95Y",
    "rxcui": "5657",
    "inchikey": "HOMGKSMUEGBAAB-UHFFFAOYSA-N",
    "display_name": "IFOSFAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b7241707-7538-4d1a-91e7-3a25a91e0b9a": {
      "match": "brand_token",
      "title": "IFEX (IFOSFAMIDE) INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "18",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0338-3993_fdee89dd-171b-4c31-9651-919cd8aaff39",
  "productndc": "0338-3993",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "019763",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Dec 30, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Dec 30, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1GM/VIAL;100MG/ML",
        "product_no": "003",
        "approval_date": "Oct 10, 1992"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "3GM/VIAL;100MG/ML",
        "product_no": "004",
        "approval_date": "Oct 10, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IFOSFAMIDE",
  "proprietary_name": "IFEX",
  "active_ingred_unit": "g/60mL",
  "application_number": "NDA019763",
  "marketing_category": "NDA",
  "nonproprietary_name": "ifosfamide",
  "start_marketing_date": "19881230",
  "active_numerator_strength": "3"
}

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