fludarabine phosphate

Generic: fludarabine phosphate

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludarabine phosphate
Generic Name fludarabine phosphate
Labeler lannett company, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fludarabine phosphate 25 mg/mL

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-1242
Product ID 0527-1242_1b10ebb9-8a76-41c8-bf18-166e54471b0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090724
Listing Expiration 2026-12-31
Marketing Start 2019-12-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05271242
Hyphenated Format 0527-1242

Supplemental Identifiers

RxCUI
1740865
UPC
0305271242020
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 ANDA090724 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0527-1242-02) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0527-1242-02 1 VIAL, SINGLE-DOSE in 1 CARTON (0527-1242-02) / 2 mL in 1 VIAL, SINGLE-DOSE

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": "1b10ebb9-8a76-41c8-bf18-166e54471b0d", "openfda": {"upc": ["0305271242020"], "unii": ["1X9VK9O1SC"], "rxcui": ["1740865"], "spl_set_id": ["0170c0f4-d502-4f8f-bdbf-6439f3ed33fb"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0527-1242-02)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0527-1242-02", "marketing_start_date": "20191231"}], "brand_name": "Fludarabine Phosphate", "product_id": "0527-1242_1b10ebb9-8a76-41c8-bf18-166e54471b0d", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "0527-1242", "generic_name": "Fludarabine Phosphate", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludarabine Phosphate", "active_ingredients": [{"name": "FLUDARABINE PHOSPHATE", "strength": "25 mg/mL"}], "application_number": "ANDA090724", "marketing_category": "ANDA", "marketing_start_date": "20191231", "listing_expiration_date": "20261231"}