fluorouracil

Generic: fluorouracil

Labeler: dr. reddy's labratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler dr. reddy's labratories inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluorouracil 50 mg/g

Manufacturer
Dr. Reddy's Labratories Inc.

Identifiers & Regulatory

Product NDC 75907-095
Product ID 75907-095_984dd0bc-f7a7-b4a9-6d64-0b45a161d9d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077524
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75907095
Hyphenated Format 75907-095

Supplemental Identifiers

RxCUI
105583
UNII
U3P01618RT
NUI
N0000000233 N0000175595

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 fluorouracil (source: ndc)
Generic Name fluorouracil (source: ndc)
Application Number ANDA077524 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (75907-095-40) / 40 g in 1 TUBE
source: ndc

Packages (1)

75907-095-40 1 TUBE in 1 CARTON (75907-095-40) / 40 g in 1 TUBE

Ingredients (1)

fluorouracil (50 mg/g)

Linked Drug Pages (1)

FLUOROURACIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "984dd0bc-f7a7-b4a9-6d64-0b45a161d9d3", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "rxcui": ["105583"], "spl_set_id": ["e137c766-1f7f-0251-90b9-450c3d4d78b9"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Labratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (75907-095-40)  / 40 g in 1 TUBE", "package_ndc": "75907-095-40", "marketing_start_date": "20240415"}], "brand_name": "FLUOROURACIL", "product_id": "75907-095_984dd0bc-f7a7-b4a9-6d64-0b45a161d9d3", "dosage_form": "CREAM", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "75907-095", "generic_name": "FLUOROURACIL", "labeler_name": "Dr. Reddy's Labratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOROURACIL", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "50 mg/g"}], "application_number": "ANDA077524", "marketing_category": "ANDA", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}