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 55150-496
Product ID 55150-496_7784c6bc-2624-42ba-a4ea-c63624eecec9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202668
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 55150496
Hyphenated Format 55150-496

Supplemental Identifiers

RxCUI
1791701 1791736
UPC
0355150496013 0355150497010
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 ANDA202668 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-496-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-496-01)
source: ndc

Packages (1)

55150-496-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-496-10) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-496-01)

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": "7784c6bc-2624-42ba-a4ea-c63624eecec9", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0355150496013", "0355150497010"], "unii": ["U3P01618RT"], "rxcui": ["1791701", "1791736"], "spl_set_id": ["199ef964-8a9b-403e-a2ae-759280b3d1d1"], "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": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-496-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (55150-496-01)", "package_ndc": "55150-496-10", "marketing_start_date": "20220408"}], "brand_name": "FLUOROURACIL", "product_id": "55150-496_7784c6bc-2624-42ba-a4ea-c63624eecec9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "55150-496", "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": "ANDA202668", "marketing_category": "ANDA", "marketing_start_date": "20220408", "listing_expiration_date": "20271231"}