floxuridine

Generic: floxuridine

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

Drug Facts

Product Profile

Brand Name floxuridine
Generic Name floxuridine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRA-ARTERIAL
Active Ingredients

floxuridine 500 mg/5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-145
Product ID 63323-145_a329ca66-d65a-4fd0-a2d9-b8e70ce3bcf8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075837
Listing Expiration 2026-12-31
Marketing Start 2001-03-15

Pharmacologic Class

Established (EPC)
antimetabolite [epc]
Chemical Structure
deoxyuridine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323145
Hyphenated Format 63323-145

Supplemental Identifiers

RxCUI
310351
UNII
039LU44I5M
NUI
N0000180853 M0006020

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 floxuridine (source: ndc)
Generic Name floxuridine (source: ndc)
Application Number ANDA075837 (source: ndc)
Routes
INTRA-ARTERIAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (63323-145-07) / 5 mL in 1 VIAL
source: ndc

Packages (1)

63323-145-07 1 VIAL in 1 CARTON (63323-145-07) / 5 mL in 1 VIAL

Ingredients (1)

floxuridine (500 mg/5mL)

Linked Drug Pages (1)

Floxuridine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTERIAL"], "spl_id": "a329ca66-d65a-4fd0-a2d9-b8e70ce3bcf8", "openfda": {"nui": ["N0000180853", "M0006020"], "unii": ["039LU44I5M"], "rxcui": ["310351"], "spl_set_id": ["c8edabc1-67cd-421b-a147-7c1f19f05b8e"], "pharm_class_cs": ["Deoxyuridine [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (63323-145-07)  / 5 mL in 1 VIAL", "package_ndc": "63323-145-07", "marketing_start_date": "20010315"}], "brand_name": "Floxuridine", "product_id": "63323-145_a329ca66-d65a-4fd0-a2d9-b8e70ce3bcf8", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antimetabolite [EPC]", "Deoxyuridine [CS]"], "product_ndc": "63323-145", "generic_name": "FLOXURIDINE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Floxuridine", "active_ingredients": [{"name": "FLOXURIDINE", "strength": "500 mg/5mL"}], "application_number": "ANDA075837", "marketing_category": "ANDA", "marketing_start_date": "20010315", "listing_expiration_date": "20261231"}