Medicine
Misoprostol 100 mcg tablet
Misoprostol 100 mcg tablet is a generic prescription medicine for oral use, made by 7 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at or below 25°C (77°F), in a dry area.
Key facts
- Active ingredient (INN)
- Misoprostol
- Brand
- Sold under the generic name
- Strength
- 100 mcg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 60 tablets, 120 tablets, 28 tablets and 14 more
- Manufacturers
- LupinIndiaNovel LaboratoriesIndiaBryant Ranch PrepackANI PharmaceuticalsMylan PharmaceuticalsNuCare Pharmaceuticals,IncAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store at or below 25°C (77°F), in a dry area.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A02BB01 Misoprostol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 December 2009
- Identifiers
- RxCUI 311727, 317128DailyMed set ID c4fe14fb-0a43-4c31-9cd6-29eb0d156705, 2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c8, c842c35f-6a64-4ecc-95a1-41b6d056047e +5NDC 59762-5007, 68071-3762, 71335-9631 +5Application NDA019268, ANDA076095, ANDA091667
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet in 1 bottle | 43386-160-06 | LupinIndia | 25 July 2012 |
| 120 tablet in 1 bottle | 43386-160-12 | LupinIndia | 25 July 2012 |
| 60 tablet in 1 bottle | 40032-160-06 | Novel LaboratoriesIndia | 25 July 2012 |
| 120 tablet in 1 bottle | 40032-160-12 | Novel LaboratoriesIndia | 25 July 2012 |
| 60 tablet in 1 bottle | 70954-443-10 | ANI Pharmaceuticals | 11 April 2022 |
| 120 tablet in 1 bottle | 70954-443-20 | ANI Pharmaceuticals | 11 April 2022 |
| 60 tablet in 1 bottle | 59762-5007-1 | Mylan Pharmaceuticals | 27 December 2009 |
| 120 tablet in 1 bottle | 59762-5007-2 | Mylan Pharmaceuticals | 27 December 2009 |
| 28 tablet in 1 bottle | 71335-2455-1 | Bryant Ranch Prepack | 20 August 2024 |
| 90 tablet in 1 bottle | 71335-2455-2 | Bryant Ranch Prepack | 20 August 2024 |
| 30 tablet in 1 bottle | 71335-2455-3 | Bryant Ranch Prepack | 20 August 2024 |
| 28 tablet in 1 bottle | 71335-9631-1 | Bryant Ranch Prepack | 31 January 2023 |
| 90 tablet in 1 bottle | 71335-9631-2 | Bryant Ranch Prepack | 31 January 2023 |
| 30 tablet in 1 bottle | 71335-9631-3 | Bryant Ranch Prepack | 31 January 2023 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 60687-735-01 | American Health Packaging | 1 April 2023 |
| 30 tablet in 1 bottle | 68071-3762-3 | NuCare Pharmaceuticals | 10 January 2025 |
| 90 tablet in 1 bottle | 68071-3762-9 | NuCare Pharmaceuticals | 14 January 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 27 December 1988 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Misoprostol 100 mcg tablet.
Other strengths and forms of Misoprostol
Clinical summary
Misoprostol is a prostaglandin E1 analog 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., among other approved uses. MedsAcross supplies Misoprostol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MisoprostolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- misoprostol prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Misoprostol 100 mcg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.