febuxostat

Generic: febuxostat

Labeler: dr reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler dr reddy's laboratories limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

febuxostat 80 mg/1

Manufacturer
DR REDDY'S LABORATORIES LIMITED

Identifiers & Regulatory

Product NDC 55111-797
Product ID 55111-797_25711455-9482-c211-793c-6d09539f1c09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205374
Listing Expiration 2026-12-31
Marketing Start 2020-11-25

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 55111797
Hyphenated Format 55111-797

Supplemental Identifiers

RxCUI
834235 834241
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 ANDA205374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (55111-797-01)
  • 500 TABLET in 1 BOTTLE (55111-797-05)
  • 30 TABLET in 1 BOTTLE (55111-797-30)
  • 90 TABLET in 1 BOTTLE (55111-797-90)
source: ndc

Packages (4)

55111-797-01 100 TABLET in 1 BOTTLE (55111-797-01) 55111-797-05 500 TABLET in 1 BOTTLE (55111-797-05) 55111-797-30 30 TABLET in 1 BOTTLE (55111-797-30) 55111-797-90 90 TABLET in 1 BOTTLE (55111-797-90)

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": "25711455-9482-c211-793c-6d09539f1c09", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["ccf2c4b1-e9a3-c7b7-ac42-79e1988fc211"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["DR REDDY'S LABORATORIES LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (55111-797-01)", "package_ndc": "55111-797-01", "marketing_start_date": "20201125"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (55111-797-05)", "package_ndc": "55111-797-05", "marketing_start_date": "20201125"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (55111-797-30)", "package_ndc": "55111-797-30", "marketing_start_date": "20201125"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (55111-797-90)", "package_ndc": "55111-797-90", "marketing_start_date": "20201125"}], "brand_name": "Febuxostat", "product_id": "55111-797_25711455-9482-c211-793c-6d09539f1c09", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "55111-797", "generic_name": "Febuxostat", "labeler_name": "DR REDDY'S LABORATORIES LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "80 mg/1"}], "application_number": "ANDA205374", "marketing_category": "ANDA", "marketing_start_date": "20201125", "listing_expiration_date": "20261231"}