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Allopurinol 300 mg Tablet, 100-count — NDC 00591-5544-01 package photo

Allopurinol 300 mg Tablet, 100-count

by Actavis Pharma, Inc. · 100 TABLET in 1 BOTTLE, PLASTIC (0591-5544-01)
NDC 00591-5544-01
🏷️ FDA NDC (as labeled) 0591-5544-01 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.0546 NADAC Per package$5.46 / 100 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.2649/unit · Part D plans $0.1123/unit — full pricing hub ↓
Also comes in: 500 tablets 00591-5544-05 20000 tablets 00591-5544-00 24000 tablets 00591-5544-77
On market Non-controlled ⚠ On shortage
🗂️ Data synced Sep 17, 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

⚠️
Active FDA shortage. Allopurinol Tablet is currently reported in shortage by the FDA. Shortage details →

🆔 Identity & classification

FDA NDC (as labeled) 0591-5544-01
Product NDC 0591-5544
11-digit billing NDC 00591554401
NCPDP billing unit EA — each (per item)
SPL Set ID a80fe56f-8d03-423f-8e2a-7ec8c9e5045b
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-04-06
Dosage form TABLET
Substance ALLOPURINOL
GPI-14 68000010000310
GPI class Allopurinol
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
Why two NDCs? The FDA registers this code as 0591-5544-01 — a 4-4-2 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 labeler segment → 00591-5544-01. 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.

🏭 Manufacturer & labeler

LabelerActavis Pharma, Inc.
Labeler code00591
First marketedApr 2009
Product typeDrug For Further Processing
Portfolio324 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.

🩺 Clinical

Label name ALLOPURINOL 300 MG TABLET Ingredient Allopurinol
📖 What it is MedlinePlus · NLM

Allopurinol is used to treat gout (a type of arthritis in which uric acid, a naturally occurring substance in the body, builds up in the joints and causes sudden attacks of redness, swelling, pain, and heat in one or more joints). Allopurinol is also used to treat high levels of uric acid that builds up in the blood as tumors break down in people with certain types of cancer who are being treated with chemotherapy medications. It is also used to treat kidney stones that have come back in people who have high levels of uric acid in their urine. Allopurinol is in a class of medications called xa...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Gout is caused by too much uric acid building up in your blood, which then forms sharp crystals in your joints — causing those painful flares. Allopurinol works by blocking the enz...
  • Why did my doctor prescribe allopurinol, and how does it actually help my gout?
  • This is really common and it doesn't mean the medicine isn't working. When uric acid levels start to drop, it can shake loose uric acid crystals from your tissues, temporarily trig...
  • I started allopurinol and I'm actually getting more gout attacks — should I stop taking it?
📖 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.

💊 What it looks like

Color white / orange
ShapeRound
ImprintDAN;DAN;5544
Size11 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 $0.055 $5.46 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2649 $26.49 / 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 2021 Jul 2022 Dec 2025 Aug 2026 $0.088 $0.055
▼ Down 38% over the last 24 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Allopurinol 300 mg 00378-0181-01 Mylan 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mgthis 00591-5544-01 Actavis 100 tablets $0.055 — Availability likely —
Allopurinol 300 mg 00603-2116-21 Par 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 00904-6572-61 Major 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 16571-0885-09 Rising 90 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 16714-0577-01 NorthStar 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 23155-0694-01 Heritage 100 tablets $0.055 AB Discontinued —
Allopurinol 300 mg 29300-0350-01 Unichem 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 31722-0253-01 Camber 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 51079-0206-20 Mylan 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 53489-0157-01 Sun 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 55111-0730-01 Dr. 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 59651-0286-01 Aurobindo 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 60687-0688-01 American 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 62135-0517-31 Chartwell 300 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 69315-0292-01 Leading 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 71921-0242-01 Florida 100 tablets $0.055 AB Availability likely —
Allopurinol 300 mg 16729-0135-01 Accord 100 tablets $0.075 AB FDA listed +37%
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: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2009
On the market since
Apr 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

🗺️ 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 00591-5544-01, 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.
📅 Q1 2025 – Q4 2025 · 4 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
1.1K
Units reimbursed last 4 qtrs
45.6K
Gross reimbursed last 4 qtrs
$12.1K
Avg / prescription
$10.52
Avg / unit
$0.2649
Latest quarter Q4 2025
208Rx
Medicaid pays / ea
$0.2649
gross reimbursed
vs
NADAC / ea
$0.0546
acquisition cost
=
Spread
+$0.2103
+385% 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 ⓘ
47% FFS 53% MCO
Fee-for-service · 539 Rx Managed care · 610 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 2,833 units · 36.3 per 100k residents WA Idaho: 1,558 units · 79.3 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 420 units · 4.2 per 100k residents MI New York: 16,355 units · 83.6 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: 1,412 units · 12.0 per 100k residents OH Pennsylvania: 3,270 units · 25.2 per 100k residents PA New Jersey: 2,116 units · 22.8 per 100k residents NJ Massachusetts: no data reported MA California: 1,917 units · 4.9 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: 4,719 units · 104 per 100k residents KY West Virginia: no data reported WV Virginia: 1,949 units · 22.4 per 100k residents VA Maryland: 319 units · 5.2 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: 404 units · 7.5 per 100k residents SC Delaware: no data reported DE Oklahoma: 475 units · 11.7 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 1,146 units · 79.9 per 100k residents HI Texas: 2,613 units · 8.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.2104
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 Kentucky 104 /100k
2 New York 83.6 /100k
3 Hawaii 79.9 /100k
4 Idaho 79.3 /100k
5 Washington 36.3 /100k
6 Pennsylvania 25.2 /100k
7 New Jersey 22.8 /100k
8 Virginia 22.4 /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 tablets00591-5544-05 1,589 Rx · $17,371
100 tablets this page00591-5544-01 1,149 Rx · $12,082
20000 tablets00591-5544-00 No Medicaid data
24000 tablets00591-5544-77 No Medicaid data
Drug total (last 4 qtrs): 2,738 Rx · 114,831 units · $29,453 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 (matched by generic name) — 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Allopurinol — the ingredient across all brands.

Top reported reactions

Diarrhoea8,726
Fatigue8,284
Dyspnoea7,956
Nausea7,333
Death6,902
Acute Kidney Injury6,761
Pyrexia6,124

Reporter sex

0 reports

Serious outcomes

Death21,968
Disabling4,384
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,180 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00591-5544-01 You're viewing this 100 TABLET in 1 BOTTLE, PLASTIC (0591-5544-01) $0.0546 / ea $5.46 2009-04-06 Active
00591-5544-05 500 TABLET in 1 BOTTLE, PLASTIC (0591-5544-05) $0.0546 / ea $27.32 2009-04-06 Active
00591-5544-00 20000 TABLET in 1 BAG (0591-5544-00) — — — Active
00591-5544-77 24000 TABLET in 1 CONTAINER (0591-5544-77) — — — Active

You're viewing the smallest of 4 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0546 NADAC).

This pack accounts for about 42% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 00591-5544-01?
NDC 00591-5544-01 is a 100-count package — 100 tablet in 1 bottle, plastic.
What is the difference between NDC 00591-5544-01 and NDC 00591-5544-05?
Both are Allopurinol 300 mg Tablet — the drug itself is identical. NDC 00591-5544-01 is the 100-count package, while NDC 00591-5544-05 is the 500 tablets package.
What NDC number is used to bill for this package of Allopurinol 300 mg Tablet?
Bill NDC 00591-5544-01 — the 11-digit billing format is 00591554401. 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.

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0591-5544-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00591-5544-01, written without dashes as 00591554401. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00591-5544-01, the first segment (00591) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (5544) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Actavis Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 500 tablets (00591-5544-05), 20000 tablets (00591-5544-00), 24000 tablets (00591-5544-77). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Actavis Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. 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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 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 is 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 is 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 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…

💊 Dosage Forms and Strengths 74 words ▾

3 DOSAGE FORMS AND STRENGTHS Allopurinol Tablets, USP are available in the following strengths: 100 mg: Round, flat-faced, beveled, scored, white tablets imprinted with “ DAN DAN ” on one side and “ 5543 ” on the other side. 300 mg: Round, standard convex, scored, orange tablets imprinted with “ DAN DAN ” on one side and “ 5544 ” on the other side. Tablets: 100 mg and 300 mg, scored ( 3 )

⛔ Contraindications 41 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 tablets. ( 4 )

⚠️ 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 Tablets 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 Tablets.

( 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 Tablets 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 Tablets 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 Tablets 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 Tablets may be increased in patients with decreased kidney function receiving thiazide diuretics and Allopurinol Tablets 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 Tablets immediately if a skin rash develops. Instruct patients to stop taking Allopurinol Tablets 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 Tablets, 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 Tablets, 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 Tablets is initiated, concurrent prophylactic treatment with colchicine or an anti-inflammatory agent is recommended [see Dosage and Administr…

🤒 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 Tablets 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 Tablets 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 Teva at 1-888-838-2872 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 tablets. ( 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 Tablets in patients with concomitant thiazide diuretic use and impaired renal function [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.1 )] .

Discontinue Allopurinol Tablets 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 Tablets Table 3: Interventions for Clinically Important Drug Interactions with Allopurinol Tablets 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 Tablets 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 Tablets 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 Tablets. 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 Tablets is given to patients already on dicumarol therapy. Intervention Monitor prothrombin time.

Adjust the dosage of dicumarol accordingly when Allopurinol Tablets 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…

👥 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 Tablets 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 Tablets during human pregnancy has been limited partly because women of reproductive age rarely require treatment with Allopurinol Tablets. 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 Tablets 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 safe…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings in animals, Allopurinol Tablets 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 Tablets during human pregnancy has been limited partly because women of reproductive age rarely require treatment with Allopurinol Tablets. 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 148 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 Tablets 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 Tablets 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 Tablets have not been established in pediatric patients with rare inborn errors of purine metabolism.

🧓 Geriatric Use 71 words ▾

8.6Renal Impairment Allopurinol and its primary active metabolite, oxipurinol, are eliminated by the kidneys; therefore, changes in renal function have a profound effect on exposure. In patients with decreased renal function or who have concurrent illnesses which can affect renal function, perform periodic laboratory parameters of renal function and reassess the patient's dosage of Allopurinol Tablets [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.3 )] .

🆘 Overdosage 40 words ▾

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

Cyclospor…

🧬 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 137 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Allopurinol Tablets is available in multiple tablet strengths and package sizes (bottles with child-resistant caps) as listed in Table 4. TABLE 4: Allopurinol Tablet Presentations Tablet Strength Tablet Description Package Sizes (NDC) 100 mg Round, flat-faced, beveled, scored, white tablets imprinted with “ DAN DAN ” on one side and “ 5543 ” on the other side Bottles of: 100 tablets (NDC 0591-5543-01) 1,000 tablets (NDC 0591-5543-10) 300 mg Round, standard convex, scored, orange tablets imprinted with “ DAN DAN ” on one side and “ 5544 ” on the other side Bottles of: 100 tablets (NDC 0591-5544-01) 500 tablets (NDC 0591-5544-05) Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Protect from light. Dispense in a tight, light-resistant container with child-resistant closure.

📋 Description 105 words ▾

11 DESCRIPTION Allopurinol, USP is a xanthine oxidase inhibitor. It has the following structural formula: Allopurinol, USP 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 37°C is 80.0 mg/dL and is greater in an alkaline solution.

It is a xanthine oxidase inhibitor which is administered orally. Allopurinol Tablets USP, 100 mg and 300 mg contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and sodium lauryl sulfate. In addition, the 300 mg strength also contains FD&C Yellow No.

6. 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 )] . Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 4/2024

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