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Sulindac

Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the pain and inflammation of several types of arthritis, acute painful shoulder and acute gout flares.

Brand name Clinoril
Drug class Nonsteroidal Anti-inflammatory Drug
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 8, 2026
Sulindac at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Sulindac (Clinoril) is an older standby NSAID, or nonsteroidal anti-inflammatory drug, on the market since about 1978 and available as a generic, that eases the pain and swelling of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis (arthritis of the spine), painful shoulder and gout flares by blocking prostaglandins, chemicals behind inflammation. Most people tolerate it reasonably well, though stomach pain, indigestion and nausea are common, which is why it is taken with food. Its boxed warning covers heart attack, stroke and serious stomach or intestinal bleeding, so use the lowest dose for the shortest time and get help fast for black stools, chest pain or one-sided weakness.

Clinical pearls

  • Avoid aspirin with sulindac, because aspirin lowers levels of sulindac's active form and adds stomach risk.
  • Do not add over-the-counter ibuprofen or naproxen for extra relief, since doubling up on NSAIDs raises stomach bleeding risk.
  • Tell whoever manages your lithium, warfarin, methotrexate or water pill that you started sulindac, since each interaction needs watching.
  • Call your doctor about ankle swelling, rapid weight gain or much less urine, which can signal fluid retention or kidney strain.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Sulindac and other NSAIDs can raise the risk of heart attack, stroke and serious stomach or intestinal bleeding, which can be fatal.

Heart risk: Heart attack and stroke can happen early in treatment and may become more likely the longer you take it. Sulindac must not be used around the time of CABG heart surgery.

Stomach risk: NSAIDs can cause bleeding, ulcers and holes (perforation) in the stomach or intestines. This can happen at any time and without warning symptoms. Older adults are at higher risk.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record1978
Companies listing it with the FDA7
FDA label last updatedOct 23, 2024
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Sulindac, written from its FDA label.

What Sulindac is used for

▾

Sulindac is an NSAID used for the relief of signs and symptoms of these conditions:

  • Osteoarthritis
  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis)
  • Acute gouty arthritis

Sulindac tablets can be used for short or long periods. Their safety and effectiveness have not been established in rheumatoid arthritis patients who are Functional Class IV (largely or wholly bedridden or wheelchair-bound).

How Sulindac works

▾

Sulindac is an NSAID. It reduces inflammation, pain and fever in animal models. Like other NSAIDs, it may work by blocking prostaglandin synthesis, although the exact mechanism is not fully understood.

Your body converts sulindac into an active form called the sulfide metabolite. This form is responsible for most of the drug's activity.

Sulindac dosage

▾

Sulindac tablets are taken by mouth twice a day with food. Your prescriber will adjust the dose and frequency based on your response. Use the lowest effective dose for the shortest time that meets your goals.

  • For arthritis conditions, some people respond within a week, while others take longer.
  • For acute painful shoulder, treatment is usually 7 to 14 days.
  • For acute gout, treatment is usually about 7 days.

Follow your prescriber's directions and the label. Ask your pharmacist what to do if you miss a dose.

Dosing details from the FDA-approved label

From the Sulindac prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
    • Recommended starting dosage is 150 mg twice a day, administered orally with food
    • The dosage may be lowered or raised depending on the response
    • Maximum: 400 mg per day; dosages above 400 mg per day are not recommended
    • Prompt response (within one week) expected in about one-half of patients; others may require longer
  • Acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis)
    • 200 mg twice a day, administered orally with food
    • After a satisfactory response the dosage may be reduced according to the response
    • Therapy for 7-14 days is usually adequate
    • Maximum: 400 mg per day; dosages above 400 mg per day are not recommended
    • Take with food
  • Acute gouty arthritis
    • 200 mg twice a day, administered orally with food
    • After a satisfactory response the dosage may be reduced according to the response
    • Therapy for 7 days is usually adequate
    • Maximum: 400 mg per day; dosages above 400 mg per day are not recommended
    • Take with food
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with sulindac tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Sulindac tablets should be administered orally twice a day with food. The maximum dosage is 400 mg per day. Dosages above 400 mg per day are not recommended. In osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, the recommended starting dosage is 150 mg twice a day. The dosage may be lowered or raised depending on the response. A prompt response (within one week) can be expected in about one-half of patients with osteoarthritis, ankylosing spondylitis, and rheumatoid arthritis. Others may require longer to respond. In acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis, the recommended dosage is 200 mg twice a day. After a satisfactory response has been achieved, the dosage may be reduced according to the response. In acute painful shoulder, therapy for 7–14 days is usually adequate. In acute gouty arthritis, therapy for 7 days is usually adequate. **Incidence between 3% and 9%. Those reactions occurring in 1% to 3% of patients are not marked with an asterisk.

Read the full Dosage and Administration section on DailyMed →

Sulindac side effects

▾

The most common side effects involve the stomach and digestion.

Common side effects

  • Stomach or abdominal pain
  • Indigestion
  • Nausea, with or without vomiting
  • Diarrhea or constipation
  • Gas, cramps or loss of appetite
  • Rash or itching
  • Dizziness or headache
  • Ringing in the ears (tinnitus) or swelling (edema)
  • Dizziness, headache and nervousness

When to get medical help

  • Call 911 or get emergency help for signs of a severe allergic reaction, such as trouble breathing, wheezing or facial swelling.
  • Get help right away for signs of a heart attack or stroke. Examples are chest pain, shortness of breath, weakness on one side or slurred speech.
  • Call your doctor if you have black or bloody stools, vomit blood, or have severe stomach pain. These can be signs of stomach or intestinal bleeding, ulcers or perforation.
  • Stop the medicine and call your doctor at the first sign of a skin rash, blistering or peeling.
  • Stop and call your doctor if you have fever, rash, swollen glands or facial swelling. These can be signs of a serious reaction called DRESS.
  • Call your doctor if you have yellow skin or eyes (jaundice), dark urine or unexplained fever. These can be signs of liver problems.
  • Call your doctor if you have swelling, rapid weight gain or worsening shortness of breath. These can be signs of fluid retention or worsening heart failure.
  • Call your doctor if you notice much less urine than usual, which can be a sign of kidney problems.

Get medical help for black or bloody stools, vomiting blood, chest pain, trouble breathing, a serious skin rash, yellow skin or eyes, or swelling of the face.

Sulindac warnings and precautions

▾
  • Heart attack and stroke: the risk can start early and may rise with longer use. Sulindac must not be used around CABG surgery.
  • Stomach and intestinal bleeding, ulcers and perforation: these can occur without warning and can be fatal. Older adults, people with a past ulcer or bleeding, smokers, alcohol users, and people taking steroid pills or blood thinners are at higher risk.
  • Blood pressure and heart failure: sulindac can raise blood pressure, cause fluid retention and worsen heart failure.
  • Liver and kidney effects: liver test changes can occur, and rare severe liver reactions have been reported. Kidney injury is possible, especially in people with kidney disease, heart failure or liver problems, or those taking diuretics or ACE inhibitors.
  • Skin and allergic reactions: serious skin reactions, DRESS and anaphylaxis can occur without warning. Stop the drug at the first sign of rash.
  • Pregnancy: avoid at about 30 weeks and later. Use at about 20 weeks or later may harm the baby's kidneys.

Sulindac interactions

▾

Sulindac can clash with several common medicines.

  • Aspirin: lowers sulindac's active form and increases stomach side effects.
  • Other NSAIDs: more stomach risk with little added benefit.
  • Warfarin and other blood thinners: a higher risk of serious bleeding together.
  • ACE inhibitors, ARBs and diuretics: weaker blood pressure or fluid effects, and a possible kidney strain.
  • Lithium: levels may rise.
  • Methotrexate and cyclosporine: possible increased toxicity.
  • DMSO: should not be used with sulindac.
  • Diflunisal: lowers sulindac's active form.

Interactions listed in the FDA-approved label

From the Sulindac prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • ACE-inhibitors and angiotensin II antagonists: NSAIDs may diminish the antihypertensive effect of ACE-inhibitors and angiotensin II antagonists, and in patients with compromised renal function co-administration may further deteriorate renal function, including possible acute renal failure, which is usually reversible. Give consideration to these interactions and monitor renal function periodically in patients receiving ACEIs or AIIAs and NSAIDs in combination.
  • Acetaminophen: Acetaminophen had no effect on the plasma levels of sulindac or its sulfide metabolite.
  • Aspirin: Aspirin significantly depressed plasma levels of the active sulfide metabolite and the combination showed an increase in the incidence of gastrointestinal adverse experiences without a favorable effect on therapeutic response. The combination is not recommended.
  • Cyclosporine: NSAIDs given with cyclosporine have been associated with an increase in cyclosporine-induced toxicity, possibly due to decreased synthesis of renal prostacyclin. Use NSAIDs with caution in patients taking cyclosporine and monitor renal function carefully.
  • Diflunisal: Concomitant use in normal volunteers lowered plasma levels of the active sulindac sulfide metabolite by approximately one-third.
  • Diuretics (furosemide and thiazides): Sulindac can reduce the natriuretic effect of furosemide and thiazides in some patients, attributed to inhibition of renal prostaglandin synthesis. Observe the patient closely for signs of renal failure and to assure diuretic efficacy.
  • DMSO: Concomitant administration has been reported to reduce plasma levels of the active sulfide metabolite, potentially reduce efficacy, and cause peripheral neuropathy. DMSO should not be used with sulindac.
  • Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance; mean minimum lithium concentration increased 15% and renal clearance decreased by approximately 20%. Observe subjects carefully for signs of lithium toxicity.
  • Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices, which may indicate they could enhance methotrexate toxicity. Use caution when NSAIDs are given with methotrexate.
  • Other NSAIDs: Concomitant use increases the possibility of gastrointestinal toxicity, with little or no increase in efficacy. Concomitant use is not recommended.
Read the label’s full interactions text

Drug Interactions ACE-Inhibitors and Angiotensin II Antagonists Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors and angiotensin II antagonists. These interactions should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors or angiotensin II antagonists. In some patients with compromised renal function (e.g., elderly patients or patients who are volume-depleted, including those on diuretic therapy) who are being treated with non-steroidal anti-inflammatory drugs, the co-administration of an NSAID and an ACE-inhibitor or an angiotensin II antagonist may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, monitor renal function periodically in patients receiving ACEIs or AIIAs and NSAIDs in combination therapy. Acetaminophen Acetaminophen had no effect on the plasma levels of sulindac or its sulfide metabolite. Aspirin The concomitant administration of aspirin with sulindac significantly depressed the plasma levels of the active sulfide metabolite. A double-blind study compared the safety and efficacy of sulindac tablets 300 or 400 mg daily given alone or with aspirin 2.4 g/day for the treatment of osteoarthritis. The addition of aspirin did not alter the types of clinical or laboratory adverse experiences for sulindac tablets; however, the combination showed an increase in the incidence of gastrointestinal adverse experiences. Since the addition of aspirin did not have a favorable effect on the therapeutic response to sulindac tablets, the combination is not recommended. Cyclosporine Administration of non-steroidal anti-inflammatory drugs concomitantly with cyclosporine has been associated with an increase in cyclosporine-induced toxicity, possibly due to decreased synthesis of renal prostacyclin. NSAIDs should be used with caution in patients taking cyclosporine, and renal function should be carefully monitored.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Sulindac

▾
  • Do not use it if you are allergic to sulindac or have had asthma, hives or allergic reactions to aspirin or other NSAIDs.
  • Do not use it around CABG heart surgery.
  • Tell your doctor about heart disease, a recent heart attack, heart failure or high blood pressure.
  • Tell your doctor about past ulcers or stomach bleeding.
  • Tell your doctor about kidney or liver disease. It is not recommended in advanced kidney disease.
  • Older adults face a higher risk of stomach and kidney problems.
  • Tell your doctor if you are pregnant or plan to be. It is not known if sulindac passes into human milk.

Sulindac overdose

▾

Overdose cases have been reported, and rarely deaths have occurred. Signs can include stupor, coma, low urine output and low blood pressure. Get emergency medical help right away. Treatment may include emptying the stomach, close observation and supportive care.

What Sulindac does in the body

▾

Sulindac has anti-inflammatory, pain-relieving and fever-reducing activity in animal models. Its action may relate to blocking prostaglandin synthesis. Its activity comes mainly from the sulfide metabolite, which blocks cyclooxygenase. Sulindac may affect kidney function less than some other NSAIDs, but kidney problems have still been reported.

How your body processes Sulindac

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Your body converts sulindac to an active sulfide form and an inactive sulfone form. The active form accounts for most of the drug's effect. About 50% of a dose is excreted in the urine and about 25% in the feces. The effective half-life is about 7.8 hours for sulindac and 16.4 hours for the active form. With twice-daily dosing, levels build up in the body. Older adults clear the drug more slowly through the kidneys.

How to store Sulindac

▾

Store at 20° to 25°C (68° to 77°F). DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

34

Supplements & herbs that interact with Sulindac

34 supplements and herbal products have documented interactions with Sulindac in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 18
  • Minor · 11
Every supplement checked against Sulindac — ranked by severity The full interaction hub: 5 major · 18 moderate · 11 minor · every one linked to its full report. Check Sulindac against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Sulindac has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Sulindac nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Sulindac: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Sulindac — the kind of thing our pharmacy team would talk through with you at the counter.

What is sulindac for?

▾
Sulindac is an NSAID that relieves pain and inflammation. It's used for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder and acute gout flares. Your doctor decides how long you need it.

How should I take it?

▾
Take it by mouth twice a day with food. That helps with stomach upset. Your prescriber will tailor the dose and timing to you, so follow their directions and the label.

What side effects should I expect?

▾
Stomach upset is the most common, including pain, indigestion, nausea, diarrhea or constipation. Some people get a rash, dizziness, headache or ringing in the ears. Call your doctor if these are bothersome or don't settle.

When should I call my doctor right away?

▾
Get help for black or bloody stools, vomiting blood, chest pain, trouble breathing, weakness on one side or slurred speech. Also call for a skin rash, fever, yellow skin or eyes, or facial swelling. These can signal serious problems, and rashes or fever mean you should stop the medicine and call.

Can I take aspirin or other pain relievers with it?

▾
Check with me first. Taking aspirin or another NSAID with sulindac isn't recommended because it raises the risk of stomach problems without helping more. Acetaminophen did not change sulindac levels.

Is sulindac safe during pregnancy?

▾
Tell your doctor if you are pregnant or planning to be. NSAIDs should be avoided at about 30 weeks and later because they can affect the baby's heart vessel. Use from about 20 weeks may also cause kidney problems in the baby.

Is Sulindac available over the counter?

▾
No. Sulindac is a prescription medicine: every Sulindac product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Sulindac first available?

▾
The earliest FDA record we hold for Sulindac is from 1978: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Sulindac was first used.

Who makes Sulindac?

▾
7 companies currently list Sulindac products in the FDA's NDC Directory, including PD-Rx Pharmaceuticals, Inc., A-S Medication Solutions, Actavis Pharma, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Sulindac on HelloPharmacist

Detailed data & references for Sulindac Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Sulindac forms and strengths (how it comes)

Sulindac is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Sulindac inactive ingredients by manufacturer.

Tablet

By mouth
How this form is used
What it may be used for
  • Sulindac tablets relieve signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
  • Sulindac tablets are also used for acute painful shoulder and acute gouty arthritis.
Important instructions
  • Sulindac tablets are taken by mouth twice a day with food.
  • Sulindac tablets should not exceed the maximum daily amount set by the label and your prescriber.
  • Sulindac tablets are usually needed for about 1 to 2 weeks for acute painful shoulder and about 1 week for acute gout.
Available strengths 2 strengths
34 FDA-listed product records ⓘ

Sulindac on the U.S. market: products, makers and brands

How Sulindac appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

7 companies list 14 Sulindac product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1978. Brand names on the directory include Clinoril; the rest are generics.

1
Dose forms ⓘ
7
Labelers (makers, repackagers, distributors)
1
Brand names
14
FDA-listed product records ⓘ
1978
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

PD-Rx Pharmaceuticals, Inc.21%
A-S Medication Solutions14%
Actavis Pharma, Inc.14%
Epic Pharma, LLC14%
PuraCap Laboratories LLC dba Blu Pharmaceuticals14%
Sun Pharmaceutical Industries, Inc.14%
Other makers7%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Sulindac is used (Medicaid data)

A general measure of how commonly Sulindac is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Sulindac is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

52,720
Medicaid prescriptions filled (Q1–Q4 2025)
$985,576 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Sulindac prescribed? Of the 1,601 medications we measure, Sulindac ranks #624 by Medicaid prescriptions — more than 61% of them.

Where Sulindac ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Sulindac product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 200 mg oral tablet is the most-dispensed Sulindac product — about 82% of these Medicaid prescriptions.

sulindac 200 MG Oral Tablet Most dispensed

43,008 Medicaid prescriptions (Q1–Q4 2025) 82% of Sulindac prescriptions shown $830,258 gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 6 of 65 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198239

sulindac 150 MG Oral Tablet

9,712 Medicaid prescriptions (Q1–Q4 2025) 18% of Sulindac prescriptions shown $155,318 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 5 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198238

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sulindac, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 11 of 95 listed Sulindac NDCs with Medicaid activity.

Compare Sulindac products

A representative set of FDA-listed product records for Sulindac — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
200 mg Oral A-S Medication Solutions × 2 listings ANDA View NDC →
150 mg Oral Actavis Pharma, Inc. ANDA View NDC →
200 mg Oral Actavis Pharma, Inc. ANDA View NDC →
150 mg Oral Epic Pharma, LLC ANDA View NDC →
200 mg Oral Epic Pharma, LLC ANDA View NDC →
150 mg Oral PD-Rx Pharmaceuticals, Inc. ANDA View NDC →
200 mg Oral PD-Rx Pharmaceuticals, Inc. × 2 listings ANDA View NDC →
200 mg Oral Proficient Rx LP ANDA View NDC →
150 mg Oral PuraCap Laboratories LLC dba Blu Pharmaceuticals ANDA View NDC →
200 mg Oral PuraCap Laboratories LLC dba Blu Pharmaceuticals ANDA View NDC →
150 mg Oral Sun Pharmaceutical Industries, Inc. ANDA View NDC →
200 mg Oral Sun Pharmaceutical Industries, Inc. ANDA View NDC →

Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Sulindac NDCs →

Sulindac recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Sulindac recalls since July 2021.

✅No Sulindac recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Sulindac RxCUI 10237 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 374003 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 199279 150 MG RxCUI 198238 200 MG RxCUI 198239

Look up RxCUI 10237 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Sulindac costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 200 mg $0.221 per tablet NDC details & price history
Tablet · Oral 150 mg $0.189 per tablet NDC details & price history
Tablet 200 mg $0.221 per tablet NDC details & price history
Tablet 150 mg $0.189 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Sulindac brand names

Sulindac is sold under one brand name in the FDA directory — Clinoril. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Clinoril

Who makes Sulindac: manufacturers and labelers

7 companies list Sulindac products with the FDA. By number of product records, the largest are PD-Rx Pharmaceuticals, Inc., A-S Medication Solutions, Actavis Pharma, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

PD-Rx Pharmaceuticals, Inc. 3 A-S Medication Solutions 2 Actavis Pharma, Inc. 2 Epic Pharma, LLC 2 PuraCap Laboratories LLC dba Blu Pharmaceuticals 2 Sun Pharmaceutical Industries, Inc. 2 Proficient Rx LP 1

Sulindac drug class (RxNorm)

Sulindac belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Acetic acid derivatives and related substances
How it works Cyclooxygenase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Sulindac page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 23, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Sulindac.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Sulindac after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
12
Finished products in the current FDA directory
14
Companies listing them (makers, repackagers, distributors)
7
FDA labeler codes behind them ⓘ
8
Linked representative label ⓘ
Sun Pharmaceutical Industries, Inc.
Linked label effective
Oct 23, 2024
Composite sections available
20
Linked SPL Set ID
a47e4259-d44b-4b7b-b517-841cb6840982
Linked SPL Document ID
2524fd49-5789-e388-e063-6394a90a2c9b
Open the linked representative label on DailyMed ↗

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HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sun Pharmaceutical Industries, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →