Fludarabine Phosphate

Orange BookUNIISPLATC L01BB05

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

Identification

ManufacturerAreva Pharmaceuticals

CountryUS (United States)

ATC codeL01BB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5992360402
1 VIAL, SINGLE-DOSE in 1 CARTON (59923-604-02) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

1X9VK9O1SC

FLUDARABINE PHOSPHATE

RxCUI 25102

Orange Book

A090724

AP1

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1X9VK9O1SC",
    "rxcui": "25102",
    "inchikey": "GIUYCYHIANZCFB-FJFJXFQQSA-N",
    "display_name": "FLUDARABINE PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "cf5255cc-91fd-4132-973b-764dba142eae": {
      "match": "brand_token",
      "title": "FLUDARABINE (FLUDARABINE PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "5",
      "published_date": "2024-10-21"
    }
  },
  "productid": "59923-604_f4b6988f-58a9-4593-e053-2a95a90afe36",
  "productndc": "59923-604",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "090724",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP1",
        "strength": "50MG/2ML (25MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 27, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUDARABINE PHOSPHATE",
  "proprietary_name": "Fludarabine Phosphate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090724",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fludarabine Phosphate",
  "start_marketing_date": "20191231",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code L01BB05.

Access this data programmatically

Query Fludarabine Phosphate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs