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United States · US · US:63323-142_8f166a04-4395-4ea1-8eda-98274f1bfec3

Ifosfamide

Orange BookUNIISPLATC L01AA06

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01AA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332314210
    1 VIAL, SINGLE-DOSE in 1 BOX (63323-142-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
UM20QQM95Y
IFOSFAMIDE
RxCUI 5657
Orange Book
A076078
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": "63323-142_8f166a04-4395-4ea1-8eda-98274f1bfec3",
  "productndc": "63323-142",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "076078",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/VIAL",
        "product_no": "001",
        "approval_date": "May 28, 2002"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "3GM/VIAL",
        "product_no": "002",
        "approval_date": "May 28, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IFOSFAMIDE",
  "proprietary_name": "Ifosfamide",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA076078",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IFOSFAMIDE",
  "start_marketing_date": "20030128",
  "active_numerator_strength": "1"
}

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