fluorouracil

Generic: fluorouracil

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorouracil
Generic Name fluorouracil
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fluorouracil 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-117
Product ID 63323-117_c346206d-110e-4358-800d-9245e59a0491
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040279
Listing Expiration 2026-12-31
Marketing Start 2017-01-02

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 63323117
Hyphenated Format 63323-117

Supplemental Identifiers

RxCUI
239177 1791701 1791736
UPC
0363323117016 0363323117009
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 ANDA040279 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-117-00)
  • 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-117-01)
source: ndc

Packages (2)

63323-117-10 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-117-00) 63323-117-20 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-117-01)

Ingredients (1)

fluorouracil (50 mg/mL)

Linked Drug Pages (6)

Fluorouracil ndc-match (0.9) Fluorouracil ndc-match (0.9) Fluorouracil ndc-match (0.9) Fluorouracil ndc-match (0.9) Fluorouracil ndc-match (0.9) Fluorouracil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c346206d-110e-4358-800d-9245e59a0491", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0363323117016", "0363323117009"], "unii": ["U3P01618RT"], "rxcui": ["239177", "1791701", "1791736"], "spl_set_id": ["c45f5286-a52b-43e5-8a6f-d0312e7da0c8"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-117-00)", "package_ndc": "63323-117-10", "marketing_start_date": "20170102"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-117-20)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-117-01)", "package_ndc": "63323-117-20", "marketing_start_date": "20170102"}], "brand_name": "Fluorouracil", "product_id": "63323-117_c346206d-110e-4358-800d-9245e59a0491", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "63323-117", "generic_name": "FLUOROURACIL", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluorouracil", "active_ingredients": [{"name": "FLUOROURACIL", "strength": "50 mg/mL"}], "application_number": "ANDA040279", "marketing_category": "ANDA", "marketing_start_date": "20170102", "listing_expiration_date": "20261231"}