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United States · US · US:10019-982_dc40762e-5ccf-402c-a7b1-4c9dee737811

Cyclophosphamide

Orange BookUNIISPLATC L01AA01

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeL01AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1001998201
    1 BOTTLE in 1 CARTON (10019-982-01) / 100 TABLET in 1 BOTTLE (10019-982-09)

Annotations

UNII (FDA Substance ID)
8N3DW7272P
CYCLOPHOSPHAMIDE
RxCUI 3002
Orange Book
N012141
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8N3DW7272P",
    "rxcui": "3002",
    "inchikey": "PWOQRKCAHTVFLB-UHFFFAOYSA-N",
    "display_name": "CYCLOPHOSPHAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "34dbffee-80e0-49c3-90e8-95713a0b7fbe": {
      "match": "brand_token",
      "title": "CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE INJECTION, SOLUTION) INJECTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "10019-982_dc40762e-5ccf-402c-a7b1-4c9dee737811",
  "productndc": "10019-982",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "012141",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOPHOSPHAMIDE",
  "proprietary_name": "Cyclophosphamide",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA012141",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Cyclophosphamide",
  "start_marketing_date": "20200807",
  "active_numerator_strength": "25"
}

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