Drug
Who makes febuxostat?
21 companies list febuxostat as a human prescription drug, including under the names ULORIC. Forms: tablet; tablet, coated; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing febuxostat
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | tablet, coated | ANDAANDA205421 | 4 | 7 |
| NuCare Pharmaceuticals,Inc.United States | tablet; tablet, film coated | ANDAANDA205443, ANDA205467, ANDA210461 | 3 | 1 |
| Dr. Reddy's Laboratories LimitedIndia | tablet | ANDAANDA205374 | 2 | 15 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA205467 | 2 | 13 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA205443 | 2 | 12 |
| Takeda Pharmaceuticals U.S.A., Inc.Germany | tablet | NDANDA021856 | 2 | 7 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA210741 | 2 | 6 |
| Hikma Pharmaceuticals USA Inc.United States | tablet | ANDAANDA205414 | 2 | 4 |
| HEC Pharm USA Inc.China | tablet | ANDAANDA213069 | 2 | 2 |
| Tris Pharma, Inc.United States | tablet | ANDAANDA210292 | 2 | 2 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA205414 | 2 | 1 |
| Lannett Company, LLCUnited States | tablet | ANDAANDA213069 | 2 | 1 |
| ASCEND Therapeutics US, LLC | tablet, film coated | ANDAANDA212924 | 2 | 0 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet; tablet, film coated | ANDAANDA205414, ANDA210461 | 2 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA210461 | 2 | 0 |
| NorthStar RxLLC | tablet, film coated | ANDAANDA205467 | 2 | 0 |
| Novadoz Pharmaceuticals LLC | tablet, film coated | ANDAANDA210461 | 2 | 0 |
| Solco healthcare U.S., LLC | tablet | ANDAANDA206266 | 2 | 0 |
| Viona Pharmaceuticals Inc. | tablet | ANDAANDA205443 | 2 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA205467 | 1 | 5 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA205443 | 1 | 1 |
Bulk ingredient listings
- MSN Organics Private LimitedIndia · 2 NDC
- Ami Lifesciences Private LimitedIndia · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Febuxostat · 1 NDC
- Indoco Remedies LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- Metrochem API Private LimitedIndia · 1 NDC
- Mylan Pharmaceuticals, Inc. · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- TAPI Croatia industries d.o.o.Croatia · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
- YiChang HEC ChangJiang Pharmaceutical Co., Ltd.China · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
2 unexpired patents list febuxostat as the active ingredient, expiring between Sept 2031 and Sept 2031. Application holder: TAKEDA PHARMACEUTICALS USA INC.
Enquiry
Common questions
- Who makes febuxostat?
- 21 companies list febuxostat as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, NuCare Pharmaceuticals,Inc., Dr. Reddy's Laboratories Limited, Sun Pharmaceutical Industries Limited, Zydus Lifesciences Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic ULORIC?
- 20 companies list febuxostat under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies febuxostat active ingredient?
- 15 companies list febuxostat as a bulk ingredient, including MSN Organics Private Limited, Ami Lifesciences Private Limited, Aurobindo Pharma Limited, Dr. Reddy's Laboratories Limited.