floxuridine

Generic: floxuridine

Labeler: jnd therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name floxuridine
Generic Name floxuridine
Labeler jnd therapeutics, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRA-ARTERIAL
Active Ingredients

floxuridine 500 mg/1

Manufacturer
JND Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 81643-9270
Product ID 81643-9270_42039e70-fc10-450f-9dec-2b0402160bda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075387
Listing Expiration 2026-12-31
Marketing Start 2022-06-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 816439270
Hyphenated Format 81643-9270

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 ANDA075387 (source: ndc)
Routes
INTRA-ARTERIAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 BOX, UNIT-DOSE (81643-9270-1) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

81643-9270-1 1 VIAL in 1 BOX, UNIT-DOSE (81643-9270-1) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

floxuridine (500 mg/1)

Linked Drug Pages (1)

Floxuridine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTERIAL"], "spl_id": "42039e70-fc10-450f-9dec-2b0402160bda", "openfda": {"nui": ["N0000180853", "M0006020"], "unii": ["039LU44I5M"], "rxcui": ["310351"], "spl_set_id": ["4681f23e-6b5e-433b-b245-3d0b4e64ebb2"], "pharm_class_cs": ["Deoxyuridine [CS]"], "pharm_class_epc": ["Antimetabolite [EPC]"], "manufacturer_name": ["JND Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX, UNIT-DOSE (81643-9270-1)  / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "81643-9270-1", "marketing_start_date": "20220609"}], "brand_name": "Floxuridine", "product_id": "81643-9270_42039e70-fc10-450f-9dec-2b0402160bda", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antimetabolite [EPC]", "Deoxyuridine [CS]"], "product_ndc": "81643-9270", "generic_name": "Floxuridine", "labeler_name": "JND Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Floxuridine", "active_ingredients": [{"name": "FLOXURIDINE", "strength": "500 mg/1"}], "application_number": "ANDA075387", "marketing_category": "ANDA", "marketing_start_date": "20220609", "listing_expiration_date": "20261231"}