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United States · US · US:62332-618_c4d00f29-b259-4ba5-933b-3908870376d8

Cyclophosphamide

Orange BookUNIISPLATC L01AA01

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6233261831
    100 CAPSULE in 1 BOTTLE (62332-618-31)

Annotations

UNII (FDA Substance ID)
8N3DW7272P
CYCLOPHOSPHAMIDE
RxCUI 3002
Orange Book
A215892
ABAB
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": "62332-618_c4d00f29-b259-4ba5-933b-3908870376d8",
  "productndc": "62332-618",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215892",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 10, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Nov 10, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOPHOSPHAMIDE",
  "proprietary_name": "Cyclophosphamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215892",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclophosphamide",
  "start_marketing_date": "20221123",
  "active_numerator_strength": "25"
}

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