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United States · US · US:14335-472_2aca7731-9fcc-4625-e063-6394a90a6020

Cyclophosphamide

Orange BookUNIISPLATC L01AA01

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

Identification

ManufacturerHainan Poly Pharm. Co., Ltd.
CountryUS (United States)
ATC codeL01AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1433547210
    1 VIAL, SINGLE-DOSE in 1 CARTON (14335-472-10) / 100 mL in 1 VIAL, SINGLE-DOSE (14335-472-01)

Annotations

UNII (FDA Substance ID)
8N3DW7272P
CYCLOPHOSPHAMIDE
RxCUI 3002
Orange Book
A218632
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",
  "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": "14335-472_2aca7731-9fcc-4625-e063-6394a90a6020",
  "productndc": "14335-472",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "218632",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1GM/VIAL",
        "product_no": "002",
        "approval_date": "Dec 26, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2GM/VIAL",
        "product_no": "003",
        "approval_date": "Dec 26, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOPHOSPHAMIDE",
  "proprietary_name": "Cyclophosphamide",
  "active_ingred_unit": "g/100mL",
  "application_number": "ANDA218632",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclophosphamide for Injection",
  "start_marketing_date": "20250103",
  "active_numerator_strength": "2"
}

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