Cyclophosphamide

Orange BookUNIISPLATC L01AA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeL01AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521913120
1 VIAL, SINGLE-DOSE in 1 CARTON (65219-131-20) / 50 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

8N3DW7272P

CYCLOPHOSPHAMIDE

RxCUI 3002

Orange Book

A204555

APAPAP

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": "INTRAVENOUS; 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": "65219-131_fadfc813-11a5-415a-9d70-06c579e7619c",
  "productndc": "65219-131",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204555",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 31, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/VIAL",
        "product_no": "002",
        "approval_date": "Oct 31, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2GM/VIAL",
        "product_no": "003",
        "approval_date": "Oct 31, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOPHOSPHAMIDE",
  "proprietary_name": "Cyclophosphamide",
  "active_ingred_unit": "g/50mL",
  "application_number": "ANDA204555",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cyclophosphamide",
  "start_marketing_date": "20231117",
  "active_numerator_strength": "1"
}

Related drugs

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