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United States · US · US:10019-925_d505027a-76e6-49f1-8ed1-3eeffe9a958b

IFOSFAMIDE

Orange BookUNIISPLATC L01AA06

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

Identification

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

Packs · 1

  • ndc11
    1001992501
    1 VIAL, SINGLE-DOSE in 1 CARTON (10019-925-01) / 20 mL in 1 VIAL, SINGLE-DOSE (10019-925-82)

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": {
    "efb1d03b-2d91-406e-8110-d3a58b8fa7cc": {
      "match": "brand_token",
      "title": "IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "12",
      "published_date": "2026-06-01"
    }
  },
  "productid": "10019-925_d505027a-76e6-49f1-8ed1-3eeffe9a958b",
  "productndc": "10019-925",
  "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        "strength": "1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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        "strength": "3GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "IFOSFAMIDE",
  "active_ingred_unit": "g/20mL",
  "application_number": "NDA019763",
  "marketing_category": "NDA",
  "nonproprietary_name": "IFOSFAMIDE",
  "start_marketing_date": "19881230",
  "active_numerator_strength": "1"
}

Related drugs

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