Febuxostat
Febuxostat is a prescription gout medicine (a xanthine oxidase inhibitor) used long-term to lower high uric acid (hyperuricemia) in adults with gout who can't use or didn't respond to allopurinol.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 28 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Febuxostat (Uloric) is a long-term gout medicine that lowers uric acid by blocking xanthine oxidase, the enzyme that makes it. It is a second choice behind allopurinol, has been on the U.S. market since about 2009, and is available as a generic. Most people tolerate it well, and the side effects they notice are usually mild nausea, diarrhea, joint pain or a rash, plus gout flares early on as stored uric acid shifts. Its boxed warning is for cardiovascular death, because gout patients with heart disease had more heart-related deaths on it than on allopurinol, so treat chest pain, shortness of breath or signs of stroke as an emergency.
Clinical pearls
- Never combine it with azathioprine or mercaptopurine, because febuxostat lets them build up to severely toxic levels.
- Early flares usually don't mean stopping it, and the colchicine or anti-inflammatory prescribed alongside is there to prevent them.
- Expect a liver blood test before you start, and report dark urine, yellowing skin or upper right belly pain.
- Stop it and get help right away for a spreading, peeling or blistering rash, or a fever with a rash.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Gout patients with established heart disease who took febuxostat had a higher rate of death from heart-related causes than those who took allopurinol.
Because of this, febuxostat should only be used if allopurinol didn't work well enough at the highest tolerated dose, caused intolerance, or isn't advisable. Your prescriber should weigh the risks and benefits when starting or continuing it. Know the warning signs of a serious heart problem, such as chest pain or shortness of breath, and seek emergency help if they occur.
Patient information guide A plain-language walkthrough of Febuxostat, written from its FDA label.
What Febuxostat is used for
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Febuxostat is used for long-term management of high uric acid in adults with gout.
- Chronic management of hyperuricemia in adults with gout who had an inadequate response to a maximally titrated dose of allopurinol, are intolerant to allopurinol, or can't be treated with allopurinol (Uloric tablets, Febuxostat tablets, and Febuxostat oral film).
- Not recommended for hyperuricemia without symptoms.
How Febuxostat works
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Febuxostat is a xanthine oxidase inhibitor. Xanthine oxidase is the enzyme that helps the body make uric acid. By blocking it, febuxostat lowers uric acid in the blood.
At therapeutic levels, it isn't expected to block other enzymes involved in purine and pyrimidine metabolism.
Febuxostat dosage
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Febuxostat is taken by mouth once daily, as a tablet or as an oral film. It can be taken with or without food and with or without antacids. Doctors usually start at a lower dose and may increase it if uric acid is still too high after about two weeks.
- Dosing is limited in severe kidney impairment.
- Flare prevention with an NSAID or colchicine is recommended when you start.
- Follow your prescriber's directions and your label.
Dosing details from the FDA-approved label
From the Febuxostat prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Gout (general recommended dosage)
- 40 mg or 80 mg once daily
- The recommended starting dosage is 40 mg once daily
- For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily
- Can be taken without regard to food or antacid use; flare prophylaxis with an NSAID or colchicine is recommended upon initiation
- Patients with severe renal impairment
- Limited to 40 mg once daily
- Maximum: 40 mg once daily
- No dose modification is necessary in mild or moderate renal impairment
- Patients with mild to moderate hepatic impairment
- No dosage modification is necessary
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. ( 2.1 ) • Patients with severe renal impairment: Limit the dosage to 40 mg once daily. ( 2.2 , 8.6 ) • Flare prophylaxis is recommended upon initiation of febuxostat tablets. ( 2.4 ) • Can be administered without regard to food or antacid use. ( 2.1 ) 2.1 Recommended Dosage The recommended febuxostat tablets dosage is 40 mg or 80 mg once daily. The recommended starting dosage of febuxostat tablets is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after two weeks, the recommended febuxostat tablets dosage is 80 mg once daily. Febuxostat tablets can be taken without regard to food or antacid use [see Clinical Pharmacology ( 12.3 )]. Concurrent prophylactic treatment with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.2 )]. 2.2 Dosage Recommendations in Patients with Renal Impairment and Hepatic Impairment The recommended dosage of febuxostat tablets is limited to 40 mg once daily in patients with severe renal impairment. No dose modification is necessary when administering febuxostat tablets in patients with mild or moderate renal impairment [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] . No dosage modification is necessary in patients with mild to moderate hepatic impairment [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . 2.3 Serum Uric Acid Level Monitoring Testing for the target serum uric acid level of less than 6 mg/dL may be performed as early as two weeks after initiating febuxostat tablets therapy. 2.4 Recommended Prophylaxis for Gout Flares Gout flares may occur after initiation of febuxostat tablets due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of febuxostat tablets. Prophylactic therapy may be beneficial for up to six months [see Clinical Studies ( 14.1 )] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Febuxostat side effects
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The most common side effects seen in studies were:
Common side effects
- Liver function test abnormalities
- Nausea
- Joint pain (arthralgia)
- Rash
- Dizziness
- Diarrhea
When to get medical help
- Call your doctor or get emergency help for chest pain, shortness of breath, or other signs of a heart problem or stroke.
- Get medical help right away for a serious skin reaction or allergic reaction, such as a spreading rash, peeling or blistering skin, or fever with a rash. Stop the medicine if this is suspected.
- Call your doctor if you have signs of liver problems: unusual tiredness, loss of appetite, pain in the upper right belly, dark urine, or yellowing of the skin or eyes.
- Tell your doctor if you have a gout flare. Flares are common early on, and you usually don't need to stop the medicine.
Febuxostat warnings and precautions
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- Cardiovascular death: a boxed warning applies, especially for people with established heart disease.
- Gout flares: common when starting; prevention medicine is recommended for up to six months.
- Liver effects: reports of liver failure, sometimes fatal. Liver tests are recommended before starting and if symptoms appear.
- Serious skin reactions: including Stevens-Johnson syndrome, DRESS, and toxic epidermal necrolysis. Stop the drug if suspected.
Febuxostat interactions
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A few medicines need special attention with febuxostat.
- Azathioprine and mercaptopurine: contraindicated, since levels can rise to severe toxicity.
- Theophylline: febuxostat changes its metabolism, so use caution.
- Other xanthine oxidase substrate drugs: levels may rise.
- Colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin, desipramine: no clinically significant interactions in studies.
Interactions listed in the FDA-approved label
From the Febuxostat prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Theophylline (xanthine oxidase substrate): Febuxostat altered the metabolism of theophylline (a substrate of XO) in humans. Use with caution when coadministering febuxostat tablets with theophylline.
- Azathioprine: Increases exposure of 6-mercaptopurine, which may lead to toxicity; plasma concentrations could increase resulting in severe toxicity. Febuxostat tablets are contraindicated in patients being treated with azathioprine.
- Mercaptopurine: Could increase plasma concentrations of mercaptopurine resulting in severe toxicity; interaction studies with drugs metabolized by XO have not been conducted. Febuxostat tablets are contraindicated in patients being treated with mercaptopurine.
- Cytotoxic chemotherapy drugs: Drug interaction studies have not been conducted and no safety data are available during cytotoxic chemotherapy.
- Colchicine: No clinically significant interaction. May be used concomitantly.
- Naproxen: No clinically significant interaction. May be used concomitantly.
- Indomethacin: No clinically significant interaction. May be used concomitantly.
- Hydrochlorothiazide: No clinically significant interaction. May be used concomitantly.
- Warfarin: No clinically significant interaction. May be used concomitantly.
- Desipramine: No clinically significant interaction. May be used concomitantly.
Read the label’s full interactions text
7 DRUG INTERACTIONS Concomitant administration of febuxostat tablets with XO substrate drugs, azathioprine or mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity. ( 7 ) 7.1 Xanthine Oxidase Substrate Drugs Febuxostat tablet is an XO inhibitor. Based on a drug interaction study in healthy patients, febuxostat altered the metabolism of theophylline (a substrate of XO) in humans [see Clinical Pharmacology (12.3) ]. Therefore, use with caution when coadministering febuxostat tablets with theophylline. A drug interaction study of febuxostat tablets and azathioprine, also metabolized by XO, showed an increase in exposure of 6-mercaptopurine which may lead to toxicity [see Clinical Pharmacology (12.3) ] . Drug interaction studies of febuxostat tablets with other drugs that are metabolized by XO (e.g., mercaptopurine) have not been conducted. Febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see Contraindications (4) ]. 7.2 Cytotoxic Chemotherapy Drugs Drug interaction studies of febuxostat tablets with cytotoxic chemotherapy have not been conducted. No data are available regarding the safety of febuxostat tablets during cytotoxic chemotherapy. 7.3 In Vivo Drug Interaction Studies Based on drug interaction studies in healthy patients, febuxostat tablets do not have clinically significant interactions with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin or desipramine [see Clinical Pharmacology (12.3) ]. Therefore, febuxostat tablets may be used concomitantly with these medications.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Febuxostat
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- Do not use with azathioprine or mercaptopurine.
- Tell your doctor about heart disease, stroke, or liver problems.
- Severe kidney impairment limits the dose.
- Not recommended when urate production is greatly increased, such as cancer, Lesch-Nyhan syndrome, or organ transplant.
- Pregnancy and breastfeeding: data are limited; discuss with your doctor.
- Not established in children. No dose change for older adults.
Febuxostat overdose
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In studies, healthy people took up to 300 mg daily for seven days without dose-limiting toxicity, and no overdoses were reported. If an overdose happens, care is symptom-based and supportive.
What Febuxostat does in the body
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Febuxostat lowers serum uric acid in a dose-dependent way and raises xanthine levels. Daily urinary uric acid excretion goes down while xanthine excretion goes up. At the usual doses, uric acid fell by about 40% to 55%. It did not affect the QTc interval (a heart rhythm measure) at studied doses.
How your body processes Febuxostat
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Febuxostat reaches peak blood levels about 1 to 1.5 hours after a dose. Food or antacids don't meaningfully change its effect on uric acid. It is highly bound to proteins in the blood and extensively broken down by the liver. It is cleared through both the liver and kidneys, with a half-life of about 5 to 8 hours. It does not accumulate with once-daily dosing.
How to store Febuxostat
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Protect from light. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Febuxostat
56 supplements and herbal products have documented interactions with Febuxostat in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 43
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Febuxostat: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Febuxostat — the kind of thing our pharmacy team would talk through with you at the counter.
What is febuxostat for?
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How do I take it?
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Why did my gout flare up after I started?
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Is it safe for my heart?
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What side effects should I watch for?
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What medicines should I avoid with it?
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Is Febuxostat available over the counter?
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When was Febuxostat first available?
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Who makes Febuxostat?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Febuxostat on HelloPharmacist
Febuxostat forms and strengths (how it comes)
Febuxostat is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Febuxostat inactive ingredients by manufacturer.
Tablet
How this form is used
- Uloric tablets are used for long-term management of hyperuricemia in adults with gout who didn't respond to, can't tolerate, or shouldn't use allopurinol.
- Febuxostat tablets have the same gout use and are not recommended for hyperuricemia without symptoms.
- Uloric and Febuxostat tablets are taken by mouth once daily, with or without food or antacids.
- Uloric and Febuxostat tablets are usually started at a lower dose and may be increased after about two weeks based on uric acid level.
- Flare prevention with an NSAID or colchicine is recommended when starting Uloric or Febuxostat tablets.
Dissolving oral film
How this form is used
- Febuxostat oral film is used for long-term management of hyperuricemia in adults with gout who didn't respond to, can't tolerate, or shouldn't use allopurinol.
- Febuxostat oral film is not recommended for hyperuricemia without symptoms.
- Febuxostat oral film is taken once daily and can be taken without regard to food or antacid use.
- Febuxostat oral film dosing is limited in severe kidney impairment; follow your prescriber's direction.
Febuxostat on the U.S. market: products, makers and brands
How Febuxostat appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
23 companies list 45 Febuxostat product records with the FDA, mostly as tablet, dissolving oral film; the earliest marketing or approval year on record is 2009. Brand names on the directory include Uloric; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Febuxostat is used (Medicaid data)
A general measure of how commonly Febuxostat is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Febuxostat is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Febuxostat prescribed? Of the 1,601 medications we measure, Febuxostat ranks #738 by Medicaid prescriptions — more than 54% of them.
Utilization by Febuxostat product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
febuxostat 40 MG Oral Tablet Most dispensed
Summed across the 12 of 75 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 834235
febuxostat 80 MG Oral Tablet
Summed across the 11 of 68 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 834241
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Febuxostat, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 23 of 143 listed Febuxostat NDCs with Medicaid activity.
Compare Febuxostat products
A representative set of FDA-listed product records for Febuxostat — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Dissolving oral film | ||||
| 40 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 80 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 💊Tablet | ||||
| 40 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 80 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 40 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 80 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 40 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 40 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 80 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 40 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 80 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 40 mg | Oral | Dr Reddy's Laboratories Limited | ANDA | View NDC → |
| 80 mg | Oral | Dr Reddy's Laboratories Limited | ANDA | View NDC → |
| 40 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 80 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 40 mg | Oral | HEC Pharm USA Inc. | ANDA | View NDC → |
| 80 mg | Oral | HEC Pharm USA Inc. | ANDA | View NDC → |
| 40 mg | Oral | Hikma Pharmaceuticals USA Inc | ANDA | View NDC → |
| 80 mg | Oral | Hikma Pharmaceuticals USA Inc | ANDA | View NDC → |
| 40 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 80 mg | Oral | Lannett Company, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 80 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 40 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 80 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 40 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 80 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 40 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 40 mg | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| 80 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 40 mg | Oral | Solco Healthcare US LLC | ANDA | View NDC → |
| 80 mg | Oral | Solco Healthcare US LLC | ANDA | View NDC → |
| 40 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 80 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 80 mg | Oral | Takeda Pharmaceuticals America, Inc. | NDA | View NDC → |
| 40 mg | Oral | Tris Pharma Inc | ANDA | View NDC → |
| 80 mg | Oral | Tris Pharma Inc | ANDA | View NDC → |
| 40 mg | Oral | Viona Pharmaceuticals Inc | ANDA | View NDC → |
| 80 mg | Oral | Viona Pharmaceuticals Inc | ANDA | View NDC → |
| 40 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 80 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
Showing 45 of 45 products — FDA National Drug Code Directory. See every product, package size and price: browse all 45 Febuxostat NDCs →
Febuxostat side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Febuxostat — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Febuxostat are diarrhoea, acute kidney injury, nausea; about 76% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Febuxostat in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Febuxostat FDA approval history
How Febuxostat went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Febuxostat was first approved by the FDA in 2009 (Brand: ULORIC · Takeda Pharms Usa); the first generic version was approved in 2019. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Febuxostat recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 3 Febuxostat recalls since July 2021, covering 5 product listings. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- 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,… Lots: Lot #: DNE0894A, Exp 07/31/2025 FDA record D-0369-2024 →
- 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,… Lots: Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025 FDA record D-0368-2024 →
- 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 Lots: Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025 FDA record D-0314-2024 →
- 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/… Lots: Lot #s: DNE0867A Exp. 06/30/2025, DNE0894B Exp. 07/31/2025 FDA record D-0265-2024 →
- 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. 259/1… Lots: Lot #s: DNE0866B Exp. 06/30/2025, DNE1045A, DNE1046B Exp. 08/31/2025 FDA record D-0264-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 73689 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 834234In current FDA listings
Look up RxCUI 73689 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Febuxostat supply and shortage status
Whether Febuxostat is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Febuxostat costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 40 mg | $0.191 per tablet | NDC details & price history |
| Tablet · Oral | 80 mg | $0.261 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 40 mg | $0.191 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 80 mg | $0.261 per tablet | NDC details & price history |
| Film · Oral | 80 mg | $0.261 each | NDC details & price history |
| Film · Oral | 40 mg | $0.191 each | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Febuxostat brand names
Febuxostat is sold under one brand name in the FDA directory — Uloric. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Febuxostat: manufacturers and labelers
23 companies list Febuxostat products with the FDA. By number of product records, the largest are NuCare Pharmaceuticals, Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Febuxostat drug class (RxNorm)
Febuxostat belongs to the Xanthine Oxidase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Febuxostat page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →