fludarabine

Generic: fludarabine phosphate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludarabine
Generic Name fludarabine phosphate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fludarabine phosphate 25 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-192
Product ID 63323-192_fc26c9ee-50de-4eff-b264-1882edd65414
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078393
Listing Expiration 2026-12-31
Marketing Start 2007-11-16

Pharmacologic Class

Classes
nucleic acid synthesis inhibitors [moa] nucleoside metabolic inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323192
Hyphenated Format 63323-192

Supplemental Identifiers

RxCUI
1740865
UNII
1X9VK9O1SC

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fludarabine (source: ndc)
Generic Name fludarabine phosphate (source: ndc)
Application Number ANDA078393 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (63323-192-02) / 2 mL in 1 VIAL
source: ndc

Packages (1)

63323-192-02 1 VIAL in 1 BOX (63323-192-02) / 2 mL in 1 VIAL

Ingredients (1)

fludarabine phosphate (25 mg/mL)

Linked Drug Pages (1)

Fludarabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fc26c9ee-50de-4eff-b264-1882edd65414", "openfda": {"unii": ["1X9VK9O1SC"], "rxcui": ["1740865"], "spl_set_id": ["cf5255cc-91fd-4132-973b-764dba142eae"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (63323-192-02)  / 2 mL in 1 VIAL", "package_ndc": "63323-192-02", "marketing_start_date": "20071116"}], "brand_name": "Fludarabine", "product_id": "63323-192_fc26c9ee-50de-4eff-b264-1882edd65414", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "63323-192", "generic_name": "FLUDARABINE PHOSPHATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludarabine", "active_ingredients": [{"name": "FLUDARABINE PHOSPHATE", "strength": "25 mg/mL"}], "application_number": "ANDA078393", "marketing_category": "ANDA", "marketing_start_date": "20071116", "listing_expiration_date": "20261231"}