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Allopurinol 300 mg Tablet, 100-count — NDC 59651-0286-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Allopurinol 300 mg Tablet, 100-count — NDC 59651-286-01 (Billing 59651-0286-01)

by Aurobindo Pharma Limited · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Allopurinol 300 mg Tablet from Aurobindo Pharma Limited, marketed since Apr 2025 and currently FDA-listed; retail pharmacies pay about $0.0522 per tablet (NADAC).

NDC 59651-0286-01
🏷️ FDA NDC (as labeled) 59651-286-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0522 NADAC Per package$5.22 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2004/unit · Part D plans $0.1123/unit — full pricing hub ↓
Product page 59651-0286-05 Also comes in: 500 tablets 59651-286-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59651-286-01
Product NDC 59651-286
11-digit billing NDC 59651028601
NCPDP billing unit EA — each (per item)
RxCUI 197319, 197320
UNII 63CZ7GJN5I
Application # ANDA215091
SPL Set ID 311ca755-c022-4251-97eb-dd9be86a993f
Established class (EPC) Xanthine Oxidase Inhibitor
Mechanism of action Xanthine Oxidase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-14
Route ORAL
Dosage form TABLET
Substance ALLOPURINOL
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 68000010000310
GCN Seq No 002536
GCN 07071
HICL code 001100
Ingredient (HICL) Allopurinol
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C7
Therapeutic class — intermediate (HIC2) Metabolic Inhibitors And Stimulants
HIC3 code C7A
Therapeutic class — specific (HIC3) Hyperuricemia Tx - Xanthine Oxidase Inhibitors
AHFS code 92:16.00.00
AHFS class Antigout Agents
FDB label name ALLOPURINOL 300 MG TABLET
FDB brand name Allopurinol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002536
  • GCN: 07071
  • GPI-14 (Medi-Span): 68000010000310
  • HICL (First Databank): 001100
  • AHFS class code: 92:16.00.00
  • RxCUI (RxNorm): 197319
Why two NDCs? The FDA registers this code as 59651-286-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59651-0286-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Xanthine Oxidase Inhibitor class.

Pharmacologic class Xanthine Oxidase Inhibitor
Drug family (ATC) Preparations inhibiting uric acid production
How it works Xanthine Oxidase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ALLOPURINOL 300 MG TABLET Ingredient Allopurinol
📗 Our plain-language guide HelloPharmacist
  • Allopurinol lowers uric acid. The tablets are used for gout, for high uric acid caused by cancer treatment, and for recurrent calcium oxalate kidney stones in certain adults. The I...
  • No. Flares can happen early as uric acid shifts, and it can take months to settle. Your doctor will likely suggest colchicine or an anti-inflammatory to help prevent them. Keep tak...
  • I got a gout flare after starting it. Should I stop?
  • Nausea, diarrhea and mild changes in liver tests are the most common. A skin rash is the one to take seriously. Stop the medicine and get medical help right away if a rash or aller...
📖 Read our full Allopurinol guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.052 $5.22 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2004 $20.04 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1123 $11.23 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.063 $0.052
▼ Down 17% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
59651-0286-01 You're viewing this 100 TABLET in 1 BOTTLE $0.0522 / ea $5.22 2025-04-14 — Active
59651-0286-05 59651-286-05 Main listing 500 TABLET in 1 BOTTLE $0.0522 / ea $26.09 2025-04-14 — Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0522 NADAC).

This pack accounts for about 1.6% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 59651-0286-05?
Both are Allopurinol 300 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 59651-0286-05 is the 500 tablets package.
What NDC number is used to bill for this package of Allopurinol 300 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Allopurinol 300 mg 00378-0181-01 Mylan 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 00591-5544-01 Actavis 100 tablets $0.052 — Availability likely —
Allopurinol 300 mg 00603-2116-21 Par 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 00904-6572-61 Major 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 16571-0885-09 Rising 90 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 16714-0577-01 NorthStar 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 23155-0694-01 Heritage 100 tablets $0.052 AB Discontinued —
Allopurinol 300 mg 29300-0350-01 Unichem 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 31722-0253-01 Camber 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 51079-0206-20 Mylan 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 53489-0157-01 Sun 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 55111-0730-01 Dr. 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mgthis 59651-0286-01 Aurobindo 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 60687-0688-01 American 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 62135-0517-31 Chartwell 300 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 69315-0292-01 Leading 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 71921-0242-01 Florida 100 tablets $0.052 AB Availability likely —
Allopurinol 300 mg 16729-0135-01 Accord 100 tablets $0.075 AB FDA listed +43%
Allopurinol 300 mg 00615-8517-05 NCS 15 tablets — AB FDA listed —
Allopurinol 300 mg 14445-0171-00 Indoco 1000 tablets — AB FDA listed —
Allopurinol 300 mg 43063-0934-01 PD-Rx 100 tablets — AB FDA listed —
Allopurinol 300 mg 43063-0976-30 PD-Rx 30 tablets — AB FDA listed —
Allopurinol 300 mg 43353-0186-60 Aphena 90 tablets — AB FDA listed —
Allopurinol 300 mg 48433-0003-20 Safecor 100 tablets — AB FDA listed —
Allopurinol 300 mg 50090-4663-00 A-S 100 tablets — AB FDA listed —
Allopurinol 300 mg 50090-6882-00 A-S 100 tablets — AB FDA listed —
Allopurinol 300 mg 50090-6968-00 A-S 90 tablets — AB FDA listed —
Allopurinol 300 mg 50090-7351-00 A-S 100 tablets — AB FDA listed —
Allopurinol 300 mg 50090-7353-00 A-S 90 tablets — AB FDA listed —
Allopurinol 300 mg 50090-7792-00 A-S 100 tablets — AB FDA listed —
Allopurinol 300 mg 51655-0782-26 Northwind 90 tablets — AB FDA listed —
Allopurinol 300 mg 51655-0968-26 Northwind 90 tablets — AB FDA listed —
Allopurinol 300 mg 55154-5454-00 Cardinal 10 tablets — AB FDA listed —
Allopurinol 300 mg 55154-7981-00 Cardinal 10 tablets — AB FDA listed —
Allopurinol 300 mg 60760-0722-90 ST. 90 tablets — AB FDA listed —
Allopurinol 300 mg 60760-0989-90 St. 90 tablets — AB FDA listed —
Allopurinol 300 mg 63187-0240-30 Proficient 30 tablets — AB FDA listed —
Allopurinol 300 mg 63629-1781-01 Bryant 30 tablets — AB FDA listed —
Allopurinol 300 mg 63629-2112-01 Bryant 500 tablets — AB FDA listed —
Allopurinol 300 mg 63629-2113-01 Bryant 1000 tablets — AB FDA listed —
Allopurinol 300 mg 67046-0681-03 Coupler 30 tablets — AB FDA listed —
Allopurinol 300 mg 67046-1514-03 Coupler 30 tablets — AB FDA listed —
Allopurinol 300 mg 67046-1639-03 Coupler 30 tablets — AB FDA listed —
Allopurinol 300 mg 67046-1658-03 Coupler 30 tablets — AB FDA listed —
Allopurinol 300 mg 67544-0313-45 Aphena 45 tablets — AB FDA listed —
Allopurinol 300 mg 68071-3605-09 NuCare 90 tablets — AB FDA listed —
Allopurinol 300 mg 68071-3672-09 NuCare 90 tablets — AB FDA listed —
Allopurinol 300 mg 68788-6323-01 Preferred 100 tablets — AB FDA listed —
Allopurinol 300 mg 68788-8364-01 Preferred 100 tablets — AB FDA listed —
Allopurinol 300 mg 68788-8424-01 Preferred 100 tablets — AB FDA listed —
Allopurinol 300 mg 68788-8713-01 Preferred 100 tablets — AB FDA listed —
Allopurinol 300 mg 68788-8865-01 Preferred 100 tablets — AB FDA listed —
Allopurinol 300 mg 70518-3704-00 REMEDYREPACK 30 tablets — AB FDA listed —
Allopurinol 300 mg 70518-4286-00 REMEDYREPACK 30 tablets — AB FDA listed —
Allopurinol 300 mg 70518-4404-00 REMEDYREPACK 30 tablets — AB FDA listed —
Allopurinol 300 mg 70518-4556-00 REMEDYREPACK 100 tablets — AB FDA listed —
Allopurinol 300 mg 70710-1210-00 Zydus 1000 tablets — AB FDA listed —
Allopurinol 300 mg 70771-1127-00 Zydus 1000 tablets — AB FDA listed —
Allopurinol 300 mg 71205-0049-30 Proficient 30 tablets — AB FDA listed —
Allopurinol 300 mg 71205-0377-30 Proficient 30 tablets — AB FDA listed —
Allopurinol 300 mg 71335-0112-01 Bryant 30 tablets — AB FDA listed —
Allopurinol 300 mg 71335-2332-01 Bryant 30 tablets — AB FDA listed —
Allopurinol 300 mg 71335-3082-01 Bryant 30 tablets — AB FDA listed —
Allopurinol 300 mg 71335-9634-01 Bryant 30 tablets — AB FDA listed —
Allopurinol 300 mg 71335-9676-01 Bryant 30 tablets — AB FDA listed —
Allopurinol 300 mg 71610-0064-45 Aphena 45 tablets — AB FDA listed —
Allopurinol 300 mg 71610-0253-60 Aphena 90 tablets — AB FDA listed —
Allopurinol 300 mg 71610-0681-45 Aphena 45 tablets — AB FDA listed —
Allopurinol 300 mg 72162-1150-00 Bryant 1000 tablets — AB FDA listed —
Allopurinol 300 mg 72189-0417-90 Direct_Rx 90 tablets — AB FDA listed —
Allopurinol 300 mg 72189-0647-90 Direct_Rx 90 tablets — AB FDA listed —
Allopurinol 300 mg 72865-0304-01 XLCare 100 tablets — AB FDA listed —
Allopurinol 300 mg 80425-0206-01 Advanced 30 tablets — AB FDA listed —
Allopurinol 300 mg 80425-0383-01 Advanced 30 tablets — AB FDA listed —
Allopurinol 300 mg 80425-0518-01 Advanced 30 tablets — AB FDA listed —
Allopurinol 300 mg 82638-0113-02 Harman 100 tablets — AB FDA listed —
Allopurinol 300 mg 82868-0099-30 Northwind 30 tablets — AB FDA listed —
Allopurinol 300 mg 70518-4693-00 REMEDYREPACK 100 tablets — AB FDA listed —
Allopurinol 300 mg 71335-3154-01 Bryant 30 tablets — AB FDA listed —
Allopurinol 300 mg 55154-0282-00 Cardinal 10 tablets — AB FDA listed —
Allopurinol 300 mg 53401-0025-60 Aphena 90 tablets — AB FDA listed —
Allopurinol 300 mg 72789-0593-90 PD-Rx 90 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA215091 (ANDA)
Labeler code59651
First marketedApr 2025
Product typeHuman Prescription Drug
Portfolio1,456 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Allopurinol tablets are indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) Limitations of Use Allopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia.

Allopurinol tablets are a xanthine oxidase inhibitor indicated for the management of: Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) ( 1 ) Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels ( 1 ) Adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes ( 1 ) Limitations of Use Allopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Gout : Prior to initiating treatment assess serum uric acid level, complete blood count, chemistry panel, liver and kidney function tests. Prophylactic treatment for gout flares is recommended. ( 2.1 , 2.2 ) Patients with normal kidney function: Initial dosage is 100 mg orally daily.

Increase by 100 mg weekly increments until serum uric acid of 6 mg/dl or less is reached (maximum 800 mg daily). ( 2.3 ) Patients with impaired kidney function: The initial dosage is 50 mg orally daily. Follow recommendations for titration in patients with renal impairment until target serum uric acid level is reached.

( 2.6 ) See complete information in the Full Prescribing Information (FPI). Hyperuricemia Associated with Cancer Therapy : The recommended dosage is: Adults: 300 mg to 800 mg orally daily. Pediatric patients: 100 mg/m 2 orally every 8 hours to 12 hours (10 mg/kg/day, maximum 800 mg/day) See complete information in the FPI.

( 2.4 , 2.6 ) Recurrent Calcium Oxalate Calculi : The recommended initial dosage in patients with normal kidney function is 200 mg to 300 mg orally daily. ( 2.5 ) Dosage in Patients with Renal Impairment: See FPI for dosage modifications in patients with renal impairment. ( 2.6 )

2.1Recommended Testing Prior to Treatment Initiation Prior to initiating treatment with allopurinol tablets in patients with gout, assess the following baseline tests: serum uric acid level, complete blood count, chemistry panel, liver function tests (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin), kidney function tests (serum creatinine and eGFR).

2.2Recommended Prophylaxis for Gout Flares Gout flares may occur after initiation of allopurinol tablets due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Flare prophylaxis with colchicine or an anti-inflammatory agent according to practice guidelines is recommended upon initiation of allopurinol tablets. While adjusting the dosage of allopurinol tablets in patients who are being treated with colchicine and/or anti-inflammatory agents, continue flare prophylaxis drugs until serum uric acid has been normalized and the patient has been free of gout flares for several months.

If a gout flare occurs during allopurinol tablets treatment, allopurinol tablets need not be discontinued. Manage the gout flare concurrently, as appropriate for the individual patient [see Warnings and Precautions (5.2) ].

2.3Recommended Dosage for Gout The initial recommended dosage for the management of gout is 100 mg orally daily, with weekly increments of 100 mg, until a serum uric acid level of 6 mg/dL or less is reached. Initiating treatment with lower dosages of allopurinol tablets and titrating slowly, decreases the risk of gout flares and drug induced serious adverse reactions. In patients with renal impairment the initial dosage is 50 mg orally daily with lower dose increases until serum uric acid level of 6 mg/dL or less is reached.

For complete dosage recommendations for patients with renal impairment see Table 1 [see Dosage and Administration (2.6) ]. The minimal effective dosage is 100 mg to 200 mg daily and the maximal recommended dosage is 800 mg daily. The appropriate dosage may be administered in divided doses or as a single equivalent dose with the 300 mg tablet.

Doses in excess of 300 mg should be administered in divided doses. Monitor patients’ kidney function during the early stages of administration of allopurinol tablets and decrease the dosage or withdraw the drug if persistent abnormalities in kidney function occur [see Dosage and Administration (2.6) , Warnings and Precautions (5.3) , Use in Specific Populations (8.6) ]. The dosage of allopurinol tablets to achieve control of gout varies with the severity of the disease.

In general, gout control is achieved with 200 mg to 300 mg daily in patients with mild gout, and with 400 mg to 600 mg daily in patients… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 84 words ▾

3 DOSAGE FORMS AND STRENGTHS Allopurinol tablets, USP have functional scoring and are available in the following strengths: 100 mg: White to off-white, uncoated, round shaped, beveled edged tablets debossed with ‘AL’ and ‘100’ separated with breakline on one side and plain surface on the other side. 300 mg: White to off-white, uncoated, round shaped, beveled edged tablets debossed with ‘AL’ and ‘300’ separated with breakline on one side and plain surface on the other side. Tablets: 100 mg, and 300 mg, functionally scored

⛔ Contraindications 37 words ▾

4 CONTRAINDICATIONS Allopurinol tablets are contraindicated in patients with a history of hypersensitivity reaction to allopurinol or to any of the ingredients of allopurinol tablets. Known hypersensitivity to allopurinol or to any of the ingredients of allopurinol.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue allopurinol at the first appearance of skin rash or other signs of hypersensitivity reaction. ( 5.1 ) Gout Flares: May occur during initiation of treatment.

Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. ( 5.2 ) Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of allopurinol.

( 5.3 ) Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. ( 5.4 ) Myelosuppression: Bone marrow suppression has been reported with allopurinol.

( 5.5 ) Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol. ( 5.6 )

5.1Skin Rash and Hypersensitivity Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients taking allopurinol [see Adverse Reactions (6) ] . These reactions occur in approximately 5 in 10,000 (0.05%) patients taking allopurinol. Other serious hypersensitivity reactions that have been reported include exfoliative, urticarial and purpuric lesions, generalized vasculitis, and irreversible hepatotoxicity.

Discontinue allopurinol permanently at the first appearance of skin rash or other signs which may indicate a hypersensitivity reaction. The HLA-B*58:01 allele is a genetic marker for severe skin reactions indicative of hypersensitivity to allopurinol. Patients who carry the HLA-B*58:01 allele are at a higher risk of allopurinol hypersensitivity syndrome (AHS), but hypersensitivity reactions have been reported in patients who do not carry this allele.

The frequency of this allele is higher in individuals of African, Asian (e.g., Han Chinese, Korean, Thai), and Native Hawaiian/Pacific Islander ancestry [see Clinical Pharmacology (12.5) ] . The use of allopurinol is not recommended in HLA- B*58:01 positive patients unless the benefits clearly outweigh the risks. Consider screening for HLA-B*5801 before starting treatment with allopurinol in patients from populations in which the prevalence of this HLA-B*5801 allele is known to be high.

Screening is generally not recommended in patients from populations in which the prevalence of HLA-B*58:01 is low, or in current allopurinol users, as the risk of SJS/TEN/DRESS is largely confined to the first few months of therapy, regardless of HLA- B*58:01 status. Hypersensitivity reactions to allopurinol may be increased in patients with decreased kidney function receiving thiazide diuretics and allopurinol concurrently. Concomitant use of the following drugs may also increase the risk of skin rash, which may be severe: bendamustine, ampicillin and amoxicillin [see Drug Interactions (7.1) ] .

Discontinue allopurinol immediately if a skin rash develops. Instruct patients to stop taking allopurinol immediately and seek medical attention promptly if they develop a rash.

5.2Gout Flares Gout flares have been reported during initiation of treatment with allopurinol, even when normal or subnormal serum uric acid levels have been attained due to the mobilization of urates from tissue deposits. Even with adequate therapy with allopurinol, it may require several months to deplete the uric acid pool sufficiently to achieve control of the flares. The flares typically become shorter and less severe after several months of therapy.

In order to prevent gout flares when treatment with allopurinol is initiated, concurrent prophylactic treatment with colchicine or an anti-inflammatory agent is recommended [see Dosage and Administration (2.2) ]. Advise patients to continue allopurinol and prophylactic treatment even if gout flar… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Skin Rash and Hypersensitivity [see Warnings and Precautions (5.1) ] Nephrotoxicity [see Warnings and Precautions (5.3) ] Hepatoxicity [see Warnings and Precautions (5.4) ] Myelosuppression [see Warnings and Precautions (5.5) ] Potential Effect on Driving and Use of Machinery [see Warnings and Precautions (5.6) ] The following adverse reactions associated with the use of allopurinol were identified in literature, unpublished clinical trials or postmarketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequent adverse reaction to allopurinol is skin rash. Most Common Adverse Reactions (≥ 1%) Gastrointestinal : Diarrhea, nausea, alkaline phosphatase increase, AST/ALT increase.

Metabolic and Nutritional : Acute attacks of gout. Skin and Appendages : Rash, maculopapular rash. Less Common Adverse Reactions (< 1%) Body As a Whole : Ecchymosis, fever, headache, malaise.

Cardiovascular : Necrotizing angiitis, vasculitis, pericarditis, peripheral vascular disease, thrombophlebitis, bradycardia, vasodilation. Gastrointestinal : Hepatic necrosis, granulomatous hepatitis, hepatomegaly, hyperbilirubinemia, cholestatic jaundice, vomiting, intermittent abdominal pain, gastritis, dyspepsia, hemorrhagic pancreatitis, gastrointestinal bleeding, stomatitis, salivary gland swelling, hyperlipidemia, tongue edema, anorexia. Hemic and Lymphatic: Thrombocytopenia, eosinophilia, leukocytosis, leukopenia, aplastic anemia, agranulocytosis, eosinophilic fibrohistiocytic lesion of bone marrow, pancytopenia, prothrombin decrease, anemia, hemolytic anemia, reticulocytosis, lymphadenopathy, lymphocytosis.

Musculoskeletal: Myopathy, arthralgias, myalgia. Nervous: Peripheral neuropathy, neuritis, paresthesia, somnolence, optic neuritis, confusion, dizziness, vertigo, foot drop, decrease in libido, depression, amnesia, tinnitus, asthenia, insomnia. Respiratory: Epistaxis, bronchospasm, asthma, pharyngitis, rhinitis.

Skin and Appendages : Erythema multiforme exudativum (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), hypersensitivity vasculitis, purpura, vesicular bullous dermatitis, exfoliative dermatitis, eczematoid dermatitis, pruritus, urticaria, alopecia, onycholysis, lichen planus, furunculosis, facial edema, sweating, skin edema. Special Senses : Taste loss/perversion, cataracts, macular retinitis, iritis, conjunctivitis, amblyopia. Urogenital: Renal failure, uremia, nephritis, impotence, primary hematuria, albuminuria.

Endocrine: Infertility (male), hypercalcemia, gynecomastia (male). Most common adverse reactions (incidence > 1%) are nausea, diarrhea, and increase in liver function tests. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS The following drugs may increase the risk of serious skin reactions: bendamustine, thiazide diuretics, ampicillin and amoxicillin. ( 7.1 ) Capecitabine: Avoid concomitant use. ( 7.2 ) Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information.

( 7.2 ) Pegloticase: Discontinue and refrain from initiating treatment with allopurinol. ( 7.2 ) See FPI for complete list of significant drug interactions. ( 7.2 )

7.1Drugs Known to Affect the Occurrence of Skin Rash and Hypersensitivity Concomitant use of the following drugs may increase the risk of skin rash, which may be severe: bendamustine, thiazide diuretics, ampicillin and amoxicillin. Renal impairment may further increase risk with concomitant use of thiazide diuretics [see Warnings and Precautions (5.1 , 5.2) and Clinical Pharmacology (12.2) ] . Monitor kidney function and reduce the dose of allopurinol in patients with concomitant thiazide diuretic use and impaired renal function [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) ].

Discontinue allopurinol at the first appearance of skin rash or other signs which may indicate a hypersensitivity reaction when use concomitantly with these drugs [see Warnings and Precautions (5.1) ] .

7.2Drugs Known to Have Clinically Important Drug Interactions with Allopurinol Table 3: Interventions for Clinically Important Drug Interactions with Allopurinol Capecitabine Clinical Impact Concomitant use with allopurinol may decrease concentration of capecitabine’s active metabolites, which may decrease capecitabine efficacy. Intervention Avoid the use of allopurinol during treatment with capecitabine Chlorpropamide Clinical Impact Allopurinol prolongs the half-life of chlorpropamide as both compete for renal tubular excretion.

In patients with renal insufficiency, the risk of hypoglycemia may be increased due to this mechanism. Intervention Monitor patients with renal insufficiency for hypoglycemia when administering chlorpropamide and allopurinol concomitantly. Cyclosporine Clinical Impact Concomitant use of allopurinol increases cyclosporine concentrations, which may increase the risk of adverse reactions.

Intervention Increase frequency of monitoring cyclosporine concentrations as reflected in its prescribing information and modify the dosage of cyclosporine as appropriate when used concomitantly with allopurinol. Cyclophosphamide and Other Cytotoxic Agents Clinical Impact Concomitant use of allopurinol with cyclophosphamide and other cytotoxic agents (doxorubicin, bleomycin, procarbazine, mechloroethamine) increases bone marrow suppression among patients with neoplastic disease, except leukemia. Intervention Blood count monitoring and regular physician follow-up are recommended.

Dicumarol Clinical Impact Allopurinol prolongs the half-life of the anticoagulant, dicumarol. The mechanism of this drug interaction has not been established but should be noted when allopurinol is given to patients already on dicumarol therapy. Intervention Monitor prothrombin time.

Adjust the dosage of dicumarol accordingly when allopurinol is added to anticoagulant therapy. Fluorouracil Clinical Impact Based on non-clinical data, allopurinol may decrease anti-tumor activity due to suppression of phosphorylation of 5-fluorouracil. Intervention Concomitant administration with fluorouracil should be avoided.

Mercaptopurine or Azathioprine Clinical Impact Allopurinol inhibits xanthine oxidase mediated metabolism of mercaptopurine and azathioprine. Concomitant use of allopurinol increases the exposure of either mercaptopurine or azathioprine which may increase the risk of their adverse reactions, including myelosuppression [see Warnings and Precautions 5.5 ]. Intervention In patients receiving mercaptopurine or azathioprine, the concomitant administration of 300 mg to 600 mg of allopurinol per day will require a reduction in dose to approximately one third… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings in animals, allopurinol may cause fetal harm when administered to a pregnant woman. Adverse developmental outcomes have been described in exposed animals (see Data). Allopurinol and its metabolite oxypurinol have been shown to cross the placenta following administration of maternal allopurinol.

Available limited published data on allopurinol use in pregnant women do not demonstrate a clear pattern or increase in frequency of adverse developmental outcomes. Among approximately 50 pregnancies described in published literature, 2 infants with major congenital malformations have been reported with following maternal allopurinol exposure. Advise pregnant women of the potential risk to a fetus.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data Experience with allopurinol during human pregnancy has been limited partly because women of reproductive age rarely require treatment with allopurinol. A case report published in 2011 described the outcome of a full-term pregnancy in a 35-year-old woman who had recurrent kidney stones since age 18 who took allopurinol throughout the pregnancy. The child had multiple complex birth defects and died at 8 days of life.

A second report in 2013 provided data on 31 prospectively ascertained pregnancies involving mothers exposed to allopurinol for varying durations during the first trimester. The overall rate of major fetal malformations and spontaneous abortions was reported to be within the normal expected range; however, one child had severe malformations similar to those described in the cited earlier case report. Animal Data There was no evidence of fetotoxicity or teratogenicity in rats or rabbits treated during the period of organogenesis with oral allopurinol at doses up to 200 mg/kg/day and up to 100 mg/kg/day, respectively (about 2.4 times the human dose on a mg/m 2 basis).

However, there is a published report in pregnant mice that single intraperitoneal doses of 50 mg/kg or 100 mg/kg (about 0.3 or 0.6 times the human dose on a mg/m 2 basis) of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects (cleft palate, harelip, and digital defects). It is uncertain whether these findings represented a fetal effect or an effect secondary to maternal toxicity.

8.2Lactation Risk Summary Allopurinol and oxypurinol are present in human milk. Based on information from a single case report, allopurinol and its active metabolite, oxypurinol, were detected in the milk of a mother receiving 300 mg of allopurinol daily at 5 weeks postpartum. The estimated relative infant dose were 0.14 mg/kg and 0.2 mg/kg of allopurinol and between 7.2 mg/kg to 8 mg/kg of oxypurinol daily.

There was no report of effects of allopurinol on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatments with allopurinol and for one week after the last dose.

8.4Pediatric Use Hyperuricemia Associated with Cancer Therapy The safety and effectiveness of allopurinol for the management of pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels have been established in approximately 200 pediatric patients. The efficacy and safety profile observed in this patient population were similar to that observed in adults. Primary or Secondary Gout The safety and effectiveness of allopurin… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings in animals, allopurinol may cause fetal harm when administered to a pregnant woman. Adverse developmental outcomes have been described in exposed animals (see Data). Allopurinol and its metabolite oxypurinol have been shown to cross the placenta following administration of maternal allopurinol.

Available limited published data on allopurinol use in pregnant women do not demonstrate a clear pattern or increase in frequency of adverse developmental outcomes. Among approximately 50 pregnancies described in published literature, 2 infants with major congenital malformations have been reported with following maternal allopurinol exposure. Advise pregnant women of the potential risk to a fetus.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Human Data Experience with allopurinol during human pregnancy has been limited partly because women of reproductive age rarely require treatment with allopurinol. A case report published in 2011 described the outcome of a full-term pregnancy in a 35-year-old woman who had recurrent kidney stones since age 18 who took allopurinol throughout the pregnancy. The child had multiple complex birth defects and died at 8 days of life.

A second report in 2013 provided data on 31 prospectively ascertained pregnancies involving mothers exposed to allopurinol for varying durations during the first trimester. The overall rate of major fetal malformations and spontaneous abortions was reported to be within the normal expected range; however, one child had severe malformations similar to those described in the cited earlier case report. Animal Data There was no evidence of fetotoxicity or teratogenicity in rats or rabbits treated during the period of organogenesis with oral allopurinol at doses up to 200 mg/kg/day and up to 100 mg/kg/day, respectively (about 2.4 times the human dose on a mg/m 2 basis).

However, there is a published report in pregnant mice that single intraperitoneal doses of 50 mg/kg or 100 mg/kg (about 0.3 or 0.6 times the human dose on a mg/m 2 basis) of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects (cleft palate, harelip, and digital defects). It is uncertain whether these findings represented a fetal effect or an effect secondary to maternal toxicity.

🧒 Pediatric Use 145 words ▾

8.4Pediatric Use Hyperuricemia Associated with Cancer Therapy The safety and effectiveness of allopurinol for the management of pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels have been established in approximately 200 pediatric patients. The efficacy and safety profile observed in this patient population were similar to that observed in adults. Primary or Secondary Gout The safety and effectiveness of allopurinol have not been established for the treatment of signs and symptoms of primary or secondary gout in pediatric patients.

Recurrent Calcium Oxalate Calculi The safety and effectiveness of allopurinol have not been established for the management of pediatric patients with recurrent calcium oxalate calculi. Inborn Errors of Metabolism The safety and effectiveness of allopurinol have not been established in pediatric patients with rare inborn errors of purine metabolism.

🆘 Overdosage 38 words ▾

10 OVERDOSAGE In the management of overdosage there is no specific antidote for allopurinol. Both allopurinol and oxipurinol are dialyzable; however, the usefulness of hemodialysis or peritoneal dialysis in the management of an overdose of allopurinol is unknown.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Allopurinol is a structural analogue of the natural purine base, hypoxanthine. Allopurinol acts on purine catabolism, without disrupting the biosynthesis of purines. It reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its formation.

It is an inhibitor of xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine and of xanthine to uric acid, the end product of purine metabolism in humans. Allopurinol is metabolized to the corresponding xanthine analogue, oxypurinol (alloxanthine), which also is an inhibitor of xanthine oxidase.

12.2Pharmacodynamics Allopurinol reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its formation in a dose dependent manner. The pharmacological action of allopurinol is generally believed to be mediated by its oxypurinol metabolite. Effect on Hypoxanthine and Xanthine Reutilization of both hypoxanthine and xanthine for nucleotide and nucleic acid synthesis is markedly enhanced when their oxidations are inhibited by allopurinol and oxipurinol.

This reutilization does not disrupt normal nucleic acid anabolism, however, because feedback inhibition is an integral part of purine biosynthesis. As a result of xanthine oxidase inhibition, the serum concentration of hypoxanthine plus xanthine in patients receiving allopurinol for treatment of hyperuricemia is usually in the range of 0.3 mg/dL to 0.4 mg/dL compared to a normal level of approximately 0.15 mg/dL. A maximum of 0.9 mg/dL of these oxypurines has been reported when the serum urate was lowered to less than 2 mg/dL by high doses of allopurinol.

These values are far below the saturation levels at which point their precipitation would be expected to occur (above 7 mg/dL). The increased xanthine and hypoxanthine in the urine in patients who were treated with oral allopurinol have not been accompanied by problems of nephrolithiasis; however, there are isolated case reports of xanthine crystalluria. Drug Interaction Studies Fluorouracil: Based on non-clinical data, allopurinol may decrease anti-tumor activity due to suppression of phosphorylation of 5-fluorouracil.

Pegloticase : Concomitant use of allopurinol and pegloticase may potentially blunt the rise of serum uric acid levels required for monitoring the safe use of pegloticase. Cytotoxic Agents : Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. Thiazide Diuretics : Reports that the concomitant administration of allopurinol and thiazide diuretics contributed to increased allopurinol toxicity were reviewed; however, a causal mechanism or cause-and-effect relationship was not found.

12.3Pharmacokinetics Absorption Allopurinol is approximately 90% absorbed from the gastrointestinal tract. Peak plasma levels generally occur at 1.5 hours and 4.5 hours for allopurinol and oxipurinol respectively. After a single oral dose of 300 mg allopurinol, maximum plasma levels of about 3 mcg/mL of allopurinol and 6.5 mcg/mL of oxipurinol are produced.

Elimination The half-life of allopurinol and oxipurinol are approximately 1 hour to 2 hours and 15 hours following oral dose of allopurinol, respectively. Metabolism Allopurinol is metabolized to the corresponding xanthine analogue, oxypurinol (alloxanthine), which also is an inhibitor of xanthine oxidase. Excretion Allopurinol and its primary active metabolite, oxipurinol, are eliminated by the kidneys.

Approximately 20% of the ingested allopurinol is excreted in the feces. Oxipurinol is primarily eliminated unchanged in urine by glomerular filtration and tubular reabsorption. Drug Interaction Studies Capecitabine: Concomitant use with allopurinol may decrease concentration of capecitabine’s active metabolites, which may decrease capecitabine efficacy.

Cyclosporin… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 91 words ▾

12.1Mechanism of Action Allopurinol is a structural analogue of the natural purine base, hypoxanthine. Allopurinol acts on purine catabolism, without disrupting the biosynthesis of purines. It reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its formation.

It is an inhibitor of xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine and of xanthine to uric acid, the end product of purine metabolism in humans. Allopurinol is metabolized to the corresponding xanthine analogue, oxypurinol (alloxanthine), which also is an inhibitor of xanthine oxidase.

📦 How Supplied / Storage and Handling 148 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Allopurinol is available in multiple tablet strengths with functional scoring and package sizes as listed below. Allopurinol Tablets, USP 100 mg are white to off-white, uncoated, round shaped, beveled edged tablets debossed with ‘AL’ and ‘100’ separated with breakline on one side and plain surface on the other side. Bottles of 100 NDC 59651-285-01 (Child Resistant Closure) Bottles of 1,000 NDC 59651-285-99 Allopurinol Tablets, USP 300 mg are white to off-white, uncoated, round shaped, beveled edged tablets debossed with ‘AL’ and ‘300’ separated with breakline on one side and plain surface on the other side.

Bottles of 100 NDC 59651-286-01 (Child Resistant Closure) Bottles of 500 NDC 59651-286-05 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP.

📋 Description 95 words ▾

11 DESCRIPTION Allopurinol, USP is a xanthine oxidase inhibitor. It has the following structural formula: Allopurinol is known chemically as 1, 5-dihydro-4 H -pyrazolo [3, 4- d ]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37ºC is 80.0 mg/dL and is greater in an alkaline solution.

It is a xanthine oxidase inhibitor which is administered orally. Each scored white to off-white tablet contains 100 mg or 300 mg allopurinol, USP and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, povidone and sodium starch glycolate. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Administration Advise patients to take allopurinol tablets after meals to minimize gastric irritation. If a single dose of allopurinol tablets is occasionally forgotten, there is no need to double the dose at the next scheduled time. Skin Rash and Hypersensitivity Inform patients that allopurinol tablets may increase the risk of serious and sometimes fatal dermatologic reactions.

Instruct patients to discontinue allopurinol tablets and to seek medical attention immediately, at the first sign of a skin rash, blisters, fever, painful urination, blood in the urine, irritation of the eyes, swelling of the lips or mouth, or other signs and symptoms of hypersensitivity reactions [see Warnings and Precautions (5.1) ]. Gout Flares During Treatment With Allopurinol Tablets Inform patients that gout flares may occur during initiation of treatment with allopurinol tablets, even when their serum uric acid is normal.

Concurrent use of additional medications such as colchicine or other anti-inflammatory agents can prevent gout flares. Advise patients to continue treatment with both, allopurinol tablets and the prophylactic therapy as prescribed, even if gout flares occur. Reassure them that it may take months to achieve control of the flares but the flares typically become shorter and less severe after several months of therapy [see Warnings and Precautions (5.2) ] .

Nephrotoxicity Inform patients that allopurinol tablets may affect kidney function. Advise them to increase fluid intake during therapy (i.e., for adults, at least 2 liters of liquids per day) and to stay well hydrated to prevent kidney stones [see Warnings and Precautions (5.3) ] . Hepatotoxicity Inform patients of the risk of hepatotoxicity and to report to their healthcare provider any signs and symptoms of liver failure, including jaundice, pruritus, bleeding, bruising, or anorexia [see Warnings and Precautions (5.4) ].

Myelosuppression Advise patients of the risk of myelosuppression and to report any signs and symptoms of infection, fever, bleeding, shortness of breath, or significant fatigue to their healthcare provider [see Warnings and Precautions (5.5) ]. Potential Effect on Driving and Use of Machinery Inform patients that drowsiness, somnolence and dizziness have been reported in patients taking allopurinol tablets. Inform also that the central nervous system depressant effects of allopurinol tablets may be additive to those of alcohol and other CNS depressants.

Advise patients to avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting allopurinol tablets or increasing the dose, until they know how the drug affects them [see Warnings and Precautions (5.6) ] . Risks Associated with Use of Concomitant Medications Inform patients that there are risks of adverse effects when allopurinol tablets are used with the following drugs: dicumarol, warfarin, sulfinpyrazone, mercaptopurine, azathioprine, ampicillin, amoxicillin, pegloticase, theophylline, and thiazide diuretics.

Advise patients to disclose all medications in use and they should follow the instructions of their physician [see Drug Interactions (7.2) ] . Pregnancy Advise pregnant women of the potential risk to a fetus. Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with allopurinol tablets [see Use in Specific Populations (8.1) ].

Lactation Advise women not to breastfeed during treatment with allopurinol tablets and for one week after the last dose [see Use in Specific Populations (8.2) ]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Issued: May 2024

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption Allopurinol is approximately 90% absorbed from the gastrointestinal tract. Peak plasma levels generally occur at 1.5 hours and 4.5 hours for allopurinol and oxipurinol respectively. After a single oral dose of 300 mg allopurinol, maximum plasma levels of about 3 mcg/mL of allopurinol and 6.5 mcg/mL of oxipurinol are produced.

Elimination The half-life of allopurinol and oxipurinol are approximately 1 hour to 2 hours and 15 hours following oral dose of allopurinol, respectively. Metabolism Allopurinol is metabolized to the corresponding xanthine analogue, oxypurinol (alloxanthine), which also is an inhibitor of xanthine oxidase. Excretion Allopurinol and its primary active metabolite, oxipurinol, are eliminated by the kidneys.

Approximately 20% of the ingested allopurinol is excreted in the feces. Oxipurinol is primarily eliminated unchanged in urine by glomerular filtration and tubular reabsorption. Drug Interaction Studies Capecitabine: Concomitant use with allopurinol may decrease concentration of capecitabine’s active metabolites, which may decrease capecitabine efficacy.

Cyclosporine: Concomitant use of allopurinol increases cyclosporine concentrations which may increase the risk of adverse reactions. Mercaptopurine or Azathioprine: Allopurinol inhibits xanthine oxidase mediated metabolism of mercaptopurine and azathioprine. Concomitant use of allopurinol increases the exposure of either mercaptopurine or azathioprine which may increase the risk of their adverse reactions including myelosuppression.

Theophylline: Concomitant use of allopurinol doses greater than or equal to 600 mg/day may decrease the clearance of theophylline. Uricosuric Agents: Uricosuric agents increase the excretion of the active allopurinol metabolite oxypurinol. Concomitant use with uricosuric agents decreases oxypurinol exposure which may reduce the inhibition of xanthine oxidase by oxypurinol and increases the urinary excretion of uric acid.

Warfarin: Allopurinol may inhibit the metabolism of warfarin, possibly enhancing its anticoagulant effect.

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Allopurinol reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its formation in a dose dependent manner. The pharmacological action of allopurinol is generally believed to be mediated by its oxypurinol metabolite. Effect on Hypoxanthine and Xanthine Reutilization of both hypoxanthine and xanthine for nucleotide and nucleic acid synthesis is markedly enhanced when their oxidations are inhibited by allopurinol and oxipurinol.

This reutilization does not disrupt normal nucleic acid anabolism, however, because feedback inhibition is an integral part of purine biosynthesis. As a result of xanthine oxidase inhibition, the serum concentration of hypoxanthine plus xanthine in patients receiving allopurinol for treatment of hyperuricemia is usually in the range of 0.3 mg/dL to 0.4 mg/dL compared to a normal level of approximately 0.15 mg/dL. A maximum of 0.9 mg/dL of these oxypurines has been reported when the serum urate was lowered to less than 2 mg/dL by high doses of allopurinol.

These values are far below the saturation levels at which point their precipitation would be expected to occur (above 7 mg/dL). The increased xanthine and hypoxanthine in the urine in patients who were treated with oral allopurinol have not been accompanied by problems of nephrolithiasis; however, there are isolated case reports of xanthine crystalluria. Drug Interaction Studies Fluorouracil: Based on non-clinical data, allopurinol may decrease anti-tumor activity due to suppression of phosphorylation of 5-fluorouracil.

Pegloticase : Concomitant use of allopurinol and pegloticase may potentially blunt the rise of serum uric acid levels required for monitoring the safe use of pegloticase. Cytotoxic Agents : Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. Thiazide Diuretics : Reports that the concomitant administration of allopurinol and thiazide diuretics contributed to increased allopurinol toxicity were reviewed; however, a causal mechanism or cause-and-effect relationship was not found.

🧪 Nonclinical Toxicology 160 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of tumorigenicity was observed in male or female mice or rats that received oral allopurinol for the majority of their life spans (greater than 88 weeks) at doses up to 20 mg/kg/day (0.1 and 0.2 times the MRHD on a mg/m 2 basis in mice and rats, respectively). Allopurinol tested negative in the following genotoxicity assays: the in vitro Ames assay, in vitro mouse lymphoma assay, and in vivo rat bone marrow micronucleus assay. Allopurinol administered intravenously to rats (50 mg/kg) was not incorporated into rapidly replicating intestinal DNA.

No evidence of clastogenicity was observed in lymphocytes taken from patients treated with allopurinol (mean duration of treatment 40 months), or in an in vitro assay with human lymphocytes. Allopurinol oral doses of 20 mg/kg/day had no effect on male or female fertility in rats or rabbits (approximately 0.2 or 0.5 times the MRHD on a mg/m 2 basis, respectively).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 157 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No evidence of tumorigenicity was observed in male or female mice or rats that received oral allopurinol for the majority of their life spans (greater than 88 weeks) at doses up to 20 mg/kg/day (0.1 and 0.2 times the MRHD on a mg/m 2 basis in mice and rats, respectively). Allopurinol tested negative in the following genotoxicity assays: the in vitro Ames assay, in vitro mouse lymphoma assay, and in vivo rat bone marrow micronucleus assay. Allopurinol administered intravenously to rats (50 mg/kg) was not incorporated into rapidly replicating intestinal DNA.

No evidence of clastogenicity was observed in lymphocytes taken from patients treated with allopurinol (mean duration of treatment 40 months), or in an in vitro assay with human lymphocytes. Allopurinol oral doses of 20 mg/kg/day had no effect on male or female fertility in rats or rabbits (approximately 0.2 or 0.5 times the MRHD on a mg/m 2 basis, respectively).

📄 Package Label / Principal Display Panel 64 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (100 Tablets Bottle) NDC 59651-285-01 Rx only Allopurinol Tablets, USP 100 mg AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (100 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg (100 Tablets Bottle) NDC 59651-286-01 Rx only Allopurinol Tablets, USP 300 mg AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg (100 Tablet Bottle)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q1 2026 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
136
Units reimbursed last 4 qtrs
6.2K
Gross reimbursed last 4 qtrs
$1.2K
Avg / prescription
$9.13
Avg / unit
$0.2004
Latest quarter Q1 2026
114Rx
Medicaid pays / ea
$0.2004
gross reimbursed
vs
NADAC / ea
$0.0522
acquisition cost
=
Spread
+$0.1482
+284% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
22% FFS 78% MCO
Fee-for-service · 30 Rx Managed care · 106 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 672 units · 8.6 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,050 units · 5.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 2,209 units · 23.8 per 100k residents NJ Massachusetts: no data reported MA California: 400 units · 1.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 554 units · 9.0 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 765 units · 16.7 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 548 units · 1.8 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.023.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 23.8 /100k
2 Louisiana 16.7 /100k
3 Maryland 9.0 /100k
4 Washington 8.6 /100k
5 New York 5.4 /100k
6 Texas 1.8 /100k
7 California 1.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
500 tablets59651-0286-05 8,519 Rx · $91,858
100 tablets this page59651-0286-01 136 Rx · $1,242
Drug total (last 4 qtrs): 8,655 Rx · 475,516 units · $93,100 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Allopurinol — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Allopurinol. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$25.19M
Claims incl. refills
2.4M
Beneficiaries
1.9M
Spend / beneficiary
$13.47
Spend / claim
$10.36
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 59651-0285-01 · Aurobindo 59651-0287-22 · Aurobindo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.