fluorouracil

Generic: fluorouracil cream, 0.5%

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil cream, 0.5%
Labeler dr. reddy's laboratories inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

fluorouracil 5 mg/g

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 75907-169
Product ID 75907-169_39a2cbc0-f588-5397-e063-6394a90a5390
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020985
Listing Expiration 2026-12-31
Marketing Start 2025-07-06

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 75907169
Hyphenated Format 75907-169

Supplemental Identifiers

RxCUI
284191
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 cream, 0.5% (source: ndc)
Application Number NDA020985 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE
source: ndc

Packages (1)

75907-169-11 1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE

Ingredients (1)

fluorouracil (5 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": "39a2cbc0-f588-5397-e063-6394a90a5390", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "rxcui": ["284191"], "spl_set_id": ["37dcfb83-0e7d-d23d-9cd5-afa5bdc30628"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (75907-169-11)  / 30 g in 1 TUBE", "package_ndc": "75907-169-11", "marketing_start_date": "20250706"}], "brand_name": "FLUOROURACIL", "product_id": "75907-169_39a2cbc0-f588-5397-e063-6394a90a5390", "dosage_form": "CREAM", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "75907-169", "generic_name": "Fluorouracil Cream, 0.5%", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOROURACIL", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "5 mg/g"}], "application_number": "NDA020985", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250706", "listing_expiration_date": "20261231"}