fludarabine phosphate

Generic: fludarabine phosphate

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludarabine phosphate
Generic Name fludarabine phosphate
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fludarabine phosphate 25 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-242
Product ID 25021-242_ec7f6839-a01c-4b1b-b4b3-5573037706dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076661
Listing Expiration 2026-12-31
Marketing Start 2016-10-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021242
Hyphenated Format 25021-242

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 phosphate (source: ndc)
Generic Name fludarabine phosphate (source: ndc)
Application Number ANDA076661 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-242-02) / 2 mL in 1 VIAL
source: ndc

Packages (1)

25021-242-02 1 VIAL in 1 CARTON (25021-242-02) / 2 mL in 1 VIAL

Ingredients (1)

fludarabine phosphate (25 mg/mL)

Linked Drug Pages (1)

Fludarabine Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ec7f6839-a01c-4b1b-b4b3-5573037706dd", "openfda": {"unii": ["1X9VK9O1SC"], "rxcui": ["1740865"], "spl_set_id": ["20e5acf0-90b7-45c8-be78-91eaf77c9ac0"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-242-02)  / 2 mL in 1 VIAL", "package_ndc": "25021-242-02", "marketing_start_date": "20161015"}], "brand_name": "Fludarabine Phosphate", "product_id": "25021-242_ec7f6839-a01c-4b1b-b4b3-5573037706dd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "25021-242", "generic_name": "Fludarabine Phosphate", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludarabine Phosphate", "active_ingredients": [{"name": "FLUDARABINE PHOSPHATE", "strength": "25 mg/mL"}], "application_number": "ANDA076661", "marketing_category": "ANDA", "marketing_start_date": "20161015", "listing_expiration_date": "20261231"}