Quick answers
- What is Misoprostol used for?
- The FDA-approved label (Cytotec, Pfizer Laboratories Div Pfizer Inc, June 4, 2026) says: “Cytotec (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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Misoprostol have a boxed warning?
- Yes. The FDA label for Cytotec has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Misoprostol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Misoprostol been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 9, 2016 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Misoprostol?
- 15 companies list prescription products of Misoprostol in the FDA NDC Directory, including GenBioPro, Inc., NuCare Pharmaceuticals, Inc. and Bryant Ranch Prepack.
What Misoprostol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cytotec (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. …
— FDA label: Cytotec, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026. Read the full label on DailyMed →
The FDA has 18 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
18 of 18 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 25 in the FDA NDC Directory |
| Brand names | Cytotec |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| misoprostol 100 ug tablet | Generic | $0.4609 per tablet |
| misoprostol 200 ug tablet | Generic | $0.6895 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- GenBioPro, Inc.3 products
- NuCare Pharmaceuticals, Inc.2 products
- Bryant Ranch Prepack2 products
- ANI Pharmaceuticals, Inc.2 products
- Lupin Pharmaceuticals, Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Pfizer Laboratories Div Pfizer Inc2 products
- Novel Laboratories, Inc.2 products
- American Health Packaging2 products
- AvPAK1 product
- PharmPak, Inc.1 product
- Cardinal Health 107, LLC1 product
- Proficient Rx LP1 product
- Redpharm Drug1 product
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019268 CYTOTEC | Pfizer | December 27, 1988 | 38, latest February 28, 2018 2018: Labeling · 2016: Labeling · 2013: Manufacturing (CMC) |
Generic approvals (3)
- ANDA076095Ani Pharms · July 10, 2002
- ANDA091667Novel Labs Inc · July 25, 2012
- ANDA210201Acq Pharma · July 2, 2019
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 9, 2016 · Class III · Terminated · D-0424-2017
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34 — Pfizer Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 104098, 209177, 311727, 317128 |
|---|---|
| SPL set ID of the quoted label | 4ab12da7-5731-4e06-bf1c-bc3f2e711f12 |
| FDA labels (SPL) | 18 |
| FDA applications | NDA019268, 3 ANDA |
| Active ingredients (FDA) | MISOPROSTOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cytotec, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →