Medicine
Diclofenac and Misoprostol 50 mg/200 mcg delayed-release tablet
Diclofenac and Misoprostol 50 mg/200 mcg delayed-release 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 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Diclofenac and Misoprostol
- Brand
- Sold under the generic name
- Strength
- 50 mg/200 mcg
- Dosage form
- Delayed-release tablet
- Route
- Oral
- Packs
- 90 tablets, 60 tablets, 30 tablets and 15 more
- Manufacturers
- Proficient RxAmneal PharmaceuticalsActavis PharmaNivagen PharmaceuticalsAvKAREBluePoint LaboratoriesBryant Ranch Prepack
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M01AB55 Diclofenac and Misoprostol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2012
- Identifiers
- RxCUI 857706, 1359105DailyMed set ID df8b8660-0c24-4848-8bea-c1b935090c66, 9a22cb4b-e49a-4bd7-b235-47405c302658, afd30051-8f59-474b-9972-962a5a871dfb +4NDC 0591-0397, 68001-231, 65162-436 +4Application ANDA201089, ANDA203995, ANDA205143
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 |
|---|---|---|---|
| 90 tablet, delayed release in 1 bottle, plastic | 0591-0397-19 | Actavis Pharma | 1 November 2012 |
| 60 tablet, delayed release in 1 bottle, plastic | 0591-0397-60 | Actavis Pharma | 1 November 2012 |
| 30 tablet, delayed release in 1 bottle | 65162-436-03 | Amneal Pharmaceuticals | 1 December 2016 |
| 60 tablet, delayed release in 1 bottle | 65162-436-06 | Amneal Pharmaceuticals | 1 December 2016 |
| 90 tablet, delayed release in 1 bottle | 65162-436-09 | Amneal Pharmaceuticals | 1 December 2016 |
| 100 tablet, delayed release in 1 bottle | 65162-436-10 | Amneal Pharmaceuticals | 1 December 2016 |
| 60 tablet, delayed release in 1 bottle | 75834-264-60 | Nivagen Pharmaceuticals | 15 July 2021 |
| 90 tablet, delayed release in 1 bottle | 75834-264-90 | Nivagen Pharmaceuticals | 15 July 2021 |
| 60 tablet, delayed release in 1 bottle | 42291-232-60 | AvKARE | 26 September 2016 |
| 60 tablet, delayed release in 1 bottle, plastic | 68001-231-06 | BluePoint Laboratories | 26 February 2014 |
| 60 tablet, delayed release in 1 bottle | 72162-2518-6 | Bryant Ranch Prepack | 15 July 2021 |
| 100 tablet, delayed release in 1 bottle | 71205-865-00 | Proficient Rx | 7 March 2022 |
| 30 tablet, delayed release in 1 bottle | 71205-865-30 | Proficient Rx | 7 March 2022 |
| 500 tablet, delayed release in 1 bottle | 71205-865-55 | Proficient Rx | 7 March 2022 |
| 60 tablet, delayed release in 1 bottle | 71205-865-60 | Proficient Rx | 7 March 2022 |
| 240 tablet, delayed release in 1 bottle | 71205-865-64 | Proficient Rx | 7 March 2022 |
| 120 tablet, delayed release in 1 bottle | 71205-865-72 | Proficient Rx | 7 March 2022 |
| 90 tablet, delayed release in 1 bottle | 71205-865-90 | Proficient Rx | 7 March 2022 |
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 24 December 1997 | 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
Other strengths and forms of Diclofenac and Misoprostol
Clinical summary
Diclofenac and Misoprostol is a fixed-dose combination of a nonsteroidal anti-inflammatory drug and a prostaglandin E1 analog. It is available as delayed-release tablets and tablets for oral use. MedsAcross supplies Diclofenac and 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 Diclofenac and 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
- Diclofenac sodium and Misoprostol prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Diclofenac and Misoprostol 50 mg/200 mcg delayed-release 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.