fludarabine phosphate

Generic: fludarabine phosphate

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludarabine phosphate
Generic Name fludarabine phosphate
Labeler actavis pharma, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fludarabine phosphate 50 mg/2mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-609
Product ID 45963-609_6ee71a09-01b9-4412-9048-a8ed9b6b0051
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078610
Listing Expiration 2026-12-31
Marketing Start 2015-01-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963609
Hyphenated Format 45963-609

Supplemental Identifiers

RxCUI
1740864
UPC
0345963609557
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 phosphate (source: ndc)
Generic Name fludarabine phosphate (source: ndc)
Application Number ANDA078610 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/2mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (45963-609-55) / 2 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

45963-609-55 1 VIAL, GLASS in 1 CARTON (45963-609-55) / 2 mL in 1 VIAL, GLASS

Ingredients (1)

fludarabine phosphate (50 mg/2mL)

Linked Drug Pages (1)

Fludarabine phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6ee71a09-01b9-4412-9048-a8ed9b6b0051", "openfda": {"upc": ["0345963609557"], "unii": ["1X9VK9O1SC"], "rxcui": ["1740864"], "spl_set_id": ["3adca34b-4f65-4e21-8058-3c01fc7fc9bb"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (45963-609-55)  / 2 mL in 1 VIAL, GLASS", "package_ndc": "45963-609-55", "marketing_start_date": "20150105"}], "brand_name": "Fludarabine phosphate", "product_id": "45963-609_6ee71a09-01b9-4412-9048-a8ed9b6b0051", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "45963-609", "generic_name": "Fludarabine phosphate", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludarabine phosphate", "active_ingredients": [{"name": "FLUDARABINE PHOSPHATE", "strength": "50 mg/2mL"}], "application_number": "ANDA078610", "marketing_category": "ANDA", "marketing_start_date": "20150105", "listing_expiration_date": "20261231"}