Quick answers
- What is Febuxostat used for?
- The FDA-approved label (Uloric, Takeda Pharmaceuticals America, Inc., December 24, 2025) says: “ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Febuxostat have a boxed warning?
- Yes. The FDA label for Uloric has a boxed warning (“WARNING: CARDIOVASCULAR DEATH”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Febuxostat?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Febuxostat been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started March 4, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Febuxostat?
- 23 companies list prescription products of Febuxostat in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., Aphena Pharma Solutions - Tennessee, LLC and Viona Pharmaceuticals Inc.
What Febuxostat is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. …
— FDA label: Uloric, Takeda Pharmaceuticals America, Inc., effective December 24, 2025. Read the full label on DailyMed →
The FDA has 26 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: CARDIOVASCULAR DEATH
. Read it on the full label →
25 of 26 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated · Tablet, coated · Film |
|---|---|
| Route | Oral |
| Prescription products | 45 in the FDA NDC Directory |
| Brand names | Uloric |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| febuxostat 40 mg film | Generic | $0.1875 per unit |
| febuxostat 40 mg tablet | Generic | $0.1875 per tablet |
| febuxostat 40 mg tablet | Brand: Uloric | $10.53 per tablet |
| febuxostat 40 mg tablet, coated | Generic | $0.1875 per tablet |
| febuxostat 40 mg tablet, film coated | Generic | $0.1875 per tablet |
| febuxostat 80 mg film | Generic | $0.2502 per unit |
| febuxostat 80 mg tablet | Generic | $0.2502 per tablet |
| febuxostat 80 mg tablet | Brand: Uloric | $10.55 per tablet |
| febuxostat 80 mg tablet, coated | Generic | $0.2502 per tablet |
| febuxostat 80 mg tablet, film coated | Generic | $0.2502 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- NuCare Pharmaceuticals, Inc.3 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Viona Pharmaceuticals Inc2 products
- NorthStar RxLLC2 products
- Tris Pharma Inc2 products
- Alembic Pharmaceuticals Inc.2 products
- Takeda Pharmaceuticals America, Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Golden State Medical Supply, Inc.2 products
- Zydus Lifesciences Limited2 products
- Macleods Pharmaceuticals Limited2 products
- Dr. Reddy's Laboratories Limited2 products
- Novadoz Pharmaceuticals LLC2 products
- Solco Healthcare US, LLC2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Lannett Company, Inc.2 products
- HEC Pharm USA Inc.2 products
- Ascend Laboratories, LLC2 products
- Major Pharmaceuticals2 products
- Aurobindo Pharma Limited2 products
- Hikma Pharmaceuticals USA Inc.2 products
- American Health Packaging1 product
- Remedyrepack Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021856 ULORIC | Takeda Pharms USA | February 13, 2009 | 9, latest April 17, 2023 2023: Labeling · 2019: Efficacy · 2018: Labeling |
Generic approvals (12)
- ANDA205421Alembic · July 1, 2019
- ANDA205467Sun Pharm · July 1, 2019
- ANDA205414Hikma · October 15, 2019
- ANDA210292Regcon Holdings · December 30, 2019
- ANDA210461Msn · December 30, 2019
- ANDA213069Sunshine · June 2, 2020
- ANDA205374DR Reddys · October 22, 2020
- ANDA212924Alkem Labs Ltd · December 7, 2021
- ANDA206266Prinston Inc · March 28, 2022
- ANDA205443Zydus Lifesciences · January 9, 2023
- ANDA207293Macleods Pharms · September 28, 2023
- ANDA210741Aurobindo Pharma Ltd · October 25, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 4, 2024 · Class II · Ongoing · D-0369-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. — SUN PHARMACEUTICAL INDUSTRIES INC
-
March 4, 2024 · Class II · Ongoing · D-0368-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. — SUN PHARMACEUTICAL INDUSTRIES INC
-
January 25, 2024 · Class II · Terminated · D-0314-2024
CGMP Deviations
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11 — Amerisource Health Services LLC
-
January 18, 2024 · Class II · Completed · D-0265-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U — SUN PHARMACEUTICAL INDUSTRIES INC
-
January 18, 2024 · Class II · Completed · D-0264-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T — SUN PHARMACEUTICAL INDUSTRIES INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 834235, 834239, 834241, 834243 |
|---|---|
| SPL set ID of the quoted label | 54de10ef-fe5f-4930-b91d-6bbb04c664bd |
| FDA labels (SPL) | 26 |
| FDA applications | NDA021856, 12 ANDA |
| Active ingredients (FDA) | FEBUXOSTAT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Uloric, Takeda Pharmaceuticals America, Inc., effective December 24, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →