fluorouracil

Generic: fluorouracil

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fluorouracil 50 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-117
Product ID 84549-117_43057fcd-1f86-cc1a-e063-6294a90a8d24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040279
Listing Expiration 2026-12-31
Marketing Start 2017-01-02

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 84549117
Hyphenated Format 84549-117

Supplemental Identifiers

RxCUI
1791701
UNII
U3P01618RT
NUI
N0000000233 N0000175595

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 ANDA040279 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, SINGLE-DOSE (84549-117-10)
source: ndc

Packages (1)

84549-117-10 10 mL in 1 VIAL, SINGLE-DOSE (84549-117-10)

Ingredients (1)

fluorouracil (50 mg/mL)

Linked Drug Pages (1)

Fluorouracil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "43057fcd-1f86-cc1a-e063-6294a90a8d24", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "rxcui": ["1791701"], "spl_set_id": ["43057fcd-1f87-cc1a-e063-6294a90a8d24"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, SINGLE-DOSE (84549-117-10)", "package_ndc": "84549-117-10", "marketing_start_date": "20251010"}], "brand_name": "Fluorouracil", "product_id": "84549-117_43057fcd-1f86-cc1a-e063-6294a90a8d24", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "84549-117", "generic_name": "FLUOROURACIL", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluorouracil", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "50 mg/mL"}], "application_number": "ANDA040279", "marketing_category": "ANDA", "marketing_start_date": "20170102", "listing_expiration_date": "20261231"}