Fludarabine Phosphate

Orange BookUNIISPLATC L01BB05

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

Identification

ManufacturerLannett Company, Inc.

CountryUS (United States)

ATC codeL01BB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0527124202
1 VIAL, SINGLE-DOSE in 1 CARTON (0527-1242-02) / 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": "0527-1242_1b10ebb9-8a76-41c8-bf18-166e54471b0d",
  "productndc": "0527-1242",
  "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

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