febuxostat

Generic: febuxostat

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

febuxostat 80 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-029
Product ID 72205-029_acca11ed-dee8-41ea-bbfb-665392250dba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210461
Listing Expiration 2027-12-31
Marketing Start 2019-12-30

Pharmacologic Class

Established (EPC)
xanthine oxidase inhibitor [epc]
Mechanism of Action
xanthine oxidase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205029
Hyphenated Format 72205-029

Supplemental Identifiers

RxCUI
834235 834241
UPC
0372205029910 0372205029309 0372205028906 0372205028050 0372205028302
UNII
101V0R1N2E
NUI
N0000175698 N0000000206

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 febuxostat (source: ndc)
Generic Name febuxostat (source: ndc)
Application Number ANDA210461 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72205-029-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72205-029-90)
  • 100 TABLET, FILM COATED in 1 BOTTLE (72205-029-91)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72205-029-99)
source: ndc

Packages (4)

72205-029-30 30 TABLET, FILM COATED in 1 BOTTLE (72205-029-30) 72205-029-90 90 TABLET, FILM COATED in 1 BOTTLE (72205-029-90) 72205-029-91 100 TABLET, FILM COATED in 1 BOTTLE (72205-029-91) 72205-029-99 1000 TABLET, FILM COATED in 1 BOTTLE (72205-029-99)

Ingredients (1)

febuxostat (80 mg/1)

Linked Drug Pages (1)

Febuxostat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "acca11ed-dee8-41ea-bbfb-665392250dba", "openfda": {"nui": ["N0000175698", "N0000000206"], "upc": ["0372205029910", "0372205029309", "0372205028906", "0372205028050", "0372205028302"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["d1969ea8-5178-42ee-97fc-feee8595e677"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72205-029-30)", "package_ndc": "72205-029-30", "marketing_start_date": "20191230"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72205-029-90)", "package_ndc": "72205-029-90", "marketing_start_date": "20260220"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72205-029-91)", "package_ndc": "72205-029-91", "marketing_start_date": "20191230"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72205-029-99)", "package_ndc": "72205-029-99", "marketing_start_date": "20191230"}], "brand_name": "Febuxostat", "product_id": "72205-029_acca11ed-dee8-41ea-bbfb-665392250dba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "72205-029", "generic_name": "Febuxostat", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "80 mg/1"}], "application_number": "ANDA210461", "marketing_category": "ANDA", "marketing_start_date": "20191230", "listing_expiration_date": "20271231"}