fluorouracil

Generic: fluorouracil

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fluorouracil 50 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-499
Product ID 55150-499_692008d1-c9e5-40d2-a935-cd49e0cb95e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202669
Listing Expiration 2027-12-31
Marketing Start 2022-04-08

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 55150499
Hyphenated Format 55150-499

Supplemental Identifiers

RxCUI
239177
UPC
0355150499014 0355150498017
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 ANDA202669 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-499-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (1)

55150-499-01 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-499-01) / 100 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": "692008d1-c9e5-40d2-a935-cd49e0cb95e5", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0355150499014", "0355150498017"], "unii": ["U3P01618RT"], "rxcui": ["239177"], "spl_set_id": ["697816ce-dc05-4943-b7f0-2f0b125e93b7"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-499-01)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "55150-499-01", "marketing_start_date": "20220408"}], "brand_name": "FLUOROURACIL", "product_id": "55150-499_692008d1-c9e5-40d2-a935-cd49e0cb95e5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "55150-499", "generic_name": "FLUOROURACIL", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOROURACIL", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "50 mg/mL"}], "application_number": "ANDA202669", "marketing_category": "ANDA", "marketing_start_date": "20220408", "listing_expiration_date": "20271231"}