fluorouracil

Generic: fluorouracil

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler alembic pharmaceuticals limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fluorouracil 50 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-779
Product ID 46708-779_b6b0d9e2-c6f0-4523-a33b-b958d32d3a28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217676
Listing Expiration 2026-12-31
Marketing Start 2023-10-18

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 46708779
Hyphenated Format 46708-779

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 ANDA217676 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (46708-779-31) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (1)

46708-779-31 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (46708-779-31) / 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": "b6b0d9e2-c6f0-4523-a33b-b958d32d3a28", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["U3P01618RT"], "rxcui": ["239177"], "spl_set_id": ["b6b0d9e2-c6f0-4523-a33b-b958d32d3a28"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (46708-779-31)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "46708-779-31", "marketing_start_date": "20231018"}], "brand_name": "Fluorouracil", "product_id": "46708-779_b6b0d9e2-c6f0-4523-a33b-b958d32d3a28", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "46708-779", "generic_name": "Fluorouracil", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluorouracil", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "50 mg/mL"}], "application_number": "ANDA217676", "marketing_category": "ANDA", "marketing_start_date": "20231018", "listing_expiration_date": "20261231"}