fluorouracil

Generic: fluorouracil

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fluorouracil 50 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-170
Product ID 71288-170_b426dddd-a31a-4897-8775-ff4eb357da09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216494
Listing Expiration 2027-12-31
Marketing Start 2024-09-24

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 71288170
Hyphenated Format 71288-170

Supplemental Identifiers

RxCUI
239177
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 ANDA216494 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-170-75) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (1)

71288-170-75 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-170-75) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE

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": "b426dddd-a31a-4897-8775-ff4eb357da09", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "rxcui": ["239177"], "spl_set_id": ["a0cd6301-c6e0-4b62-8683-39c99913db24"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-170-75)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "71288-170-75", "marketing_start_date": "20240924"}], "brand_name": "Fluorouracil", "product_id": "71288-170_b426dddd-a31a-4897-8775-ff4eb357da09", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "71288-170", "generic_name": "Fluorouracil", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluorouracil", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "50 mg/mL"}], "application_number": "ANDA216494", "marketing_category": "ANDA", "marketing_start_date": "20240924", "listing_expiration_date": "20271231"}