fluorouracil

Generic: fluorouracil

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fluorouracil 50 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-292
Product ID 68083-292_4680580c-772c-490d-bde9-c506c961e0b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210124
Listing Expiration 2026-12-31
Marketing Start 2018-01-05

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 68083292
Hyphenated Format 68083-292

Supplemental Identifiers

RxCUI
239177
UPC
0368083292010 0368083293017
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 ANDA210124 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-292-01) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (1)

68083-292-01 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-292-01) / 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": "4680580c-772c-490d-bde9-c506c961e0b8", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0368083292010", "0368083293017"], "unii": ["U3P01618RT"], "rxcui": ["239177"], "spl_set_id": ["ea3497db-23b9-4ace-9a6f-b54853d04a82"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-292-01)  / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "68083-292-01", "marketing_start_date": "20180105"}], "brand_name": "Fluorouracil", "product_id": "68083-292_4680580c-772c-490d-bde9-c506c961e0b8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68083-292", "generic_name": "Fluorouracil", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluorouracil", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "50 mg/mL"}], "application_number": "ANDA210124", "marketing_category": "ANDA", "marketing_start_date": "20180105", "listing_expiration_date": "20261231"}