Misoprostol 200 ug Tablet, 3-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Prostaglandin E1 Analog class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Misoprostol is used to prevent ulcers in people who take certain arthritis or pain medicines, including aspirin, that can cause ulcers. It protects the stomach lining and decreases stomach acid secretion.
Read the full MedlinePlus article ↗- Your pain reliever — an NSAID like ibuprofen, aspirin, or diclofenac — is effective, but it can reduce your stomach's natural defenses and raise the risk of stomach ulcers over tim...
- Why was I prescribed misoprostol along with my pain reliever?
- Unfortunately, no — and it's worth knowing this upfront. Misoprostol is designed to prevent ulcers from forming, not to relieve the everyday stomach discomfort or pain that NSAIDs...
- Will misoprostol help with the stomach pain my pain reliever causes?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Misoprostol — tap one for details:
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💊 What it looks like
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🧪 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.
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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.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII ZF94AP8MEY
Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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
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💲 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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.8629 | $2.59 / 3 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Misoprostol 200 ug 43386-0161-01 | Lupin | 100 tablets | $0.666 | — | FDA listed | — |
| Misoprostol 200 ug 43393-0023-04 | GenBioPro, | 4 tablets | $0.700 | AB | FDA listed | — |
| Misoprostol 200 ug 43393-0024-04 | GenBioPro, | 4 tablets | $0.734 | AB | Availability likely | — |
| Misoprostol 200 ug 43393-0200-48 | GenBioPro, | 48 tablets | $0.734 | AB | Availability likely | — |
| Misoprostol 200 ug 50268-0555-60 | AvPAK | 60 tablets | $0.734 | AB | Availability likely | — |
| misoprostol 200 ug 59762-5008-01 | Mylan | 60 tablets | $0.734 | AB | Availability likely | — |
| Misoprostol 200 ug 60687-0746-01 | American | 100 tablets | $0.734 | AB | Availability likely | — |
| Misoprostol 200 ug 70954-0444-10 | ANI | 60 tablets | $0.734 | AB | Availability likely | — |
| Cytotec 200 ug 00025-1461-31 | Pfizer | 100 tablets | — | AB | FDA listed | — |
| Misoprostol 200 ug 40032-0161-01 | Novel | 100 tablets | — | — | FDA listed | — |
| Misoprostol 200 ug 42571-0254-01 | Micro | 100 tablets | — | AB | Discontinued | — |
| Misoprostol 200 ugthis 54348-0148-03 | PharmPak, | 3 tablets | — | — | FDA listed | — |
| Misoprostol 200 ug 55154-2145-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| misoprostol 200 ug 67296-1936-01 | Redpharm | 10 tablets | — | AB | FDA listed | — |
| Misoprostol 200 ug 68071-4843-03 | NuCare | 3 tablets | — | — | FDA listed | — |
| Misoprostol 200 ug 72789-0300-04 | PD-Rx | 4 tablets | — | AB | FDA listed | — |
| Misoprostol 200 ug 82804-0037-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 54348-0148-00 | 1 BOTTLE in 1 BOX (54348-148-00) / 1 TABLET in 1 BOTTLE | 2019-07-10 | Active |
| 54348-0148-01 | 1 BOTTLE in 1 BOX (54348-148-01) / 1 TABLET in 1 BOTTLE | 2019-07-10 | Active |
| 54348-0148-02 | 1 BOTTLE in 1 BOX (54348-148-02) / 2 TABLET in 1 BOTTLE | 2019-07-10 | Active |
| 54348-0148-03 You're viewing this | 1 BOTTLE in 1 BOX (54348-148-03) / 3 TABLET in 1 BOTTLE | 2019-07-10 | Active |
| 54348-0148-04 | 1 BOTTLE in 1 BOX (54348-148-04) / 4 TABLET in 1 BOTTLE | 2019-07-10 | Active |
| 54348-0148-06 | 1 BOTTLE in 1 BOX (54348-148-06) / 6 TABLET in 1 BOTTLE | 2019-07-10 | Active |
| 54348-0148-08 | 1 BOTTLE in 1 BOX (54348-148-08) / 8 TABLET in 1 BOTTLE | 2019-07-10 | Active |
| 54348-0148-09 | 1 BOTTLE in 1 BOX (54348-148-09) / 9 TABLET in 1 BOTTLE | 2019-07-10 | Active |
Pack size FAQ
What quantity is in NDC 54348-0148-03?
What is the difference between NDC 54348-0148-03 and NDC 54348-0148-00?
What NDC number is used to bill for this package of Misoprostol 200 ug Tablet?
🧭 About this NDC listing & data coverage
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) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, OR PREMATURE BIRTH. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL TABLETS WERE ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see also PRECAUTIONS and LABOR AND DELIVERY ). MISOPROSTOL TABLETS SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) (see CONTRAINDICATIONS, WARNINGS , and PRECAUTIONS ).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. Misoprostol Tablets should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, Misoprostol Tablets may be prescribed if the patient has had a negative serum pregnancy test within 2 weeks prior to beginning therapy. is capable of complying with effective contraceptive measures. has received both oral and written warnings of the hazards of Misoprostol Tablets, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake. will begin Misoprostol Tablets only on the second or third day of the next normal menstrual period.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol Tablet has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol Tablets should be taken for the duration of NSAID therapy.
Misoprostol Tablets has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology : Clinical studies .) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician.
Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.
⛔ Contraindications ▾
CONTRAINDICATIONS See boxed WARNINGS . Misoprostol Tablets should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs). Misoprostol Tablets should not be taken by anyone with a history of allergy to prostaglandins.
⚠️ Warnings ▾
WARNINGS See boxed WARNINGS . For hospital use only if misoprostol were to be used for cervical ripening, induction of labor, or for the treatment of serious post-partum hemorrhage, which are outside of the approved indication.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following have been reported as adverse events in subjects receiving Misoprostol Tablets: Gastrointestinal: In subjects receiving Misoprostol Tablets 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14 to 40% and in all studies (over 5,000 patients) averaged 13%. Abdominal pain occurred in 13 to 20% of patients in NSAID trials and about 7% in all studies, but there was no consistent difference from placebo.
Diarrhea was dose related and usually developed early in the course of therapy (after 13 days), usually was self-limiting (often resolving after 8 days), but sometimes required discontinuation of Misoprostol Tablets (2% of the patients). Rare instances of profound diarrhea leading to severe dehydration have been reported. Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if Misoprostol Tablets is prescribed.
The incidence of diarrhea can be minimized by administering after meals and at bedtime, and by avoiding coadministration of Misoprostol Tablets with magnesium-containing antacids. Gynecological: Women who received Misoprostol Tablets during clinical trials reported the following gynecological disorders: spotting (0.7%), cramps (0.6%), hypermenorrhea (0.5%), menstrual disorder (0.3%) and dysmenorrhea (0.1%). Postmenopausal vaginal bleeding may be related to Misoprostol Tablets administration.
If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology. (See boxed WARNINGS .) Elderly: There were no significant differences in the safety profile of Misoprostol Tablets in approximately 500 ulcer patients who were 65 years of age or older compared with younger patients. Additional adverse events which were reported are categorized as follows: Incidence greater than 1%: In clinical trials, the following adverse reactions were reported by more than 1% of the subjects receiving Misoprostol Tablets and may be causally related to the drug: nausea (3.2%), flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%).
However, there were no significant differences between the incidences of these events for Misoprostol Tablets and placebo. Causal relationship unknown: The following adverse events were infrequently reported. Causal relationships between Misoprostol Tablets and these events have not been established but cannot be excluded: Body as a whole: aches/pains, asthenia, fatigue, fever, chills, rigors, weight changes.
Skin: rash, dermatitis, alopecia, pallor, breast pain. Special senses: abnormal taste, abnormal vision, conjunctivitis, deafness, tinnitus, earache. Respiratory: upper respiratory tract infection, bronchitis, bronchospasm, dyspnea, pneumonia, epistaxis.
Cardiovascular: chest pain, edema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope, myocardial infarction (some fatal), thromboembolic events (e.g., pulmonary embolism, arterial thrombosis, and CVA). Gastrointestinal: GI bleeding, GI inflammation/infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, amylase increase. Hypersensitivity: anaphylactic reaction Metabolic: glycosuria, gout, increased nitrogen, increased alkaline phosphatase.
Genitourinary: polyuria, dysuria, hematuria, urinary tract infection. Nervous system/Psychiatric: anxiety, change in appetite, depression, drowsiness, dizziness, thirst, impotence, loss of libido, sweating increase, neuropathy, neurosis, confusion. Musculoskeletal: arthralgia, myalgia, muscle cramps, stiffness, back pain.
Blood/Coagulation: anemia, abnormal differential, thrombocytopenia, purpura, ESR increased.
🔄 Drug Interactions ▾
Drug Interactions See Clinical Pharmacology . Misoprostol Tablets has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol Tablets does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin.
Misoprostol Tablets has no clinically significant effect on the kinetics of diclofenac or ibuprofen. Prostaglandins such as Misoprostol Tablets may augment the activity of oxytocic agents, especially when given less than 4 hours prior to initiating oxytocin treatment. Concomitant use is not recommended.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of Misoprostol Tablets in pediatric patients have not been established.
🆘 Overdosage ▾
OVERDOSAGE The toxic dose of Misoprostol Tablets in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported. In animals, the acute toxic effects are diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system.
Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. Symptoms should be treated with supportive therapy. It is not known if misoprostol acid is dialyzable.
However, because misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. The alpha side chain undergoes beta oxidation and the beta side chain undergoes omega oxidation followed by reduction of the ketone to give prostaglandin F analogs. In normal volunteers, misoprostol is rapidly absorbed after oral administration with a T max of misoprostol acid of 12 ± 3 minutes and a terminal half-life of 20 to 40 minutes.
There is high variability of plasma levels of misoprostol acid between and within studies but mean values after single doses show a linear relationship with dose over the range of 200 to 400 mcg. No accumulation of misoprostol acid was noted in multiple dose studies; plasma steady state was achieved within two days. Maximum plasma concentrations of misoprostol acid are diminished when the dose is taken with food and total availability of misoprostol acid is reduced by use of concomitant antacid.
Clinical trials were conducted with concomitant antacid, however, so this effect does not appear to be clinically important. Mean ± SD Cmax (pg/ml) AUC(0–4) (pg·hr/ml) Tmax (min) Fasting 811 ± 317 417 ± 135 14 ± 8 With Antacid 689 ± 315 349 ± 108* 20 ± 14 With High Fat Breakfast 303 ± 176* 373 ± 111 64 ± 79* *Comparisons with fasting results statistically significant, p<0.05. After oral administration of radiolabeled misoprostol, about 80% of detected radioactivity appears in urine.
Pharmacokinetic studies in patients with varying degrees of renal impairment showed an approximate doubling of T 1/2 , C max , and AUC compared to normals, but no clear correlation between the degree of impairment and AUC. In subjects over 64 years of age, the AUC for misoprostol acid is increased. No routine dosage adjustment is recommended in older patients or patients with renal impairment, but dosage may need to be reduced if the usual dose is not tolerated.
Drug interaction studies between misoprostol and several nonsteroidal anti-inflammatory drugs showed no effect on the kinetics of ibuprofen or diclofenac, and a 20% decrease in aspirin AUC, not thought to be clinically significant. Pharmacokinetic studies also showed a lack of drug interaction with antipyrine and propranolol when these drugs were given with misoprostol. Misoprostol given for 1 week had no effect on the steady state pharmacokinetics of diazepam when the two drugs were administered 2 hours apart.
The serum protein binding of misoprostol acid is less than 90% and is concentration-independent in the therapeutic range. After a single oral dose of misoprostol to nursing mothers, misoprostol acid was excreted in breast milk. The maximum concentration of misoprostol acid in expressed breast milk was achieved within 1 hour after dosing and was 7.6 pg/mL (CV 37%) and 20.9 pg/ml (CV 62%) after single 200 µg and 600 µg misoprostol administration, respectively.
The misoprostol acid concentrations in breast milk declined to < 1 pg/ml at 5 hours post-dose. Pharmacodynamics Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents.
Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 mcg and above that are also antisecretory. It is therefore not possible to tell whether the ability of misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both. In vitro studies on canine parietal cells using tritiated misoprostol acid as the ligand have led to the identification and characterization of specific prostaglandin receptors.
Receptor binding…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Misoprostol Tablets 200-mcg tablets are round, white flat-faced beveled edge bisected tablets, debossed "161" above the bisect and "n" below the bisect and plain on the other side; supplied as: Bottles of 1: 54348-148-00 Bottles of 1: 54348-148-01 Bottles of 2: 54348-148-02 Bottles of 3: 54348-148-03 Bottles of 4: 54348-148-04 Bottles of 6: 54348-148-06 Bottles of 8: 54348-148-08 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store in a dry area.
📋 Description ▾
DESCRIPTION Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±): Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated castor oil, microcrystalline cellulose, and crospovidone cf380ce8-figure-01
💬 Information for Patients ▾
Information for Patients Women of childbearing potential using Misoprostol Tablets to decrease the risk of NSAID-induced ulcers should be told that they must not be pregnant when Misoprostol Tablets therapy is initiated, and that they must use an effective contraception method while taking Misoprostol Tablets. See boxed WARNINGS . Misoprostol Tablets is intended for administration along with nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, to decrease the chance of developing an NSAID-induced gastric ulcer.
Misoprostol Tablets should be taken only according to the directions given by a physician. If the patient has questions about or problems with Misoprostol Tablets, the physician should be contacted promptly. THE PATIENT SHOULD NOT GIVE MISOPROSTOL TABLETS TO ANYONE ELSE.
Misoprostol Tablets has been prescribed for the patient's specific condition, may not be the correct treatment for another person, and may be dangerous to the other person if she were to become pregnant. The Misoprostol Tablets package the patient receives from the pharmacist will include a leaflet containing patient information. The patient should read the leaflet before taking Misoprostol Tablets and each time the prescription is renewed because the leaflet may have been revised.
Keep Misoprostol Tablets out of the reach of children. SPECIAL NOTE FOR WOMEN: Misoprostol Tablets may cause birth defects, abortion (sometimes incomplete), or premature labor if given to pregnant women. Misoprostol Tablets is available only as a unit-of-use package that includes a leaflet containing patient information.
See Patient Information at the end of this labeling.