Medicine
Arthrotec 50 mg/200 mcg tablet
Arthrotec 50 mg/200 mcg tablet is a prescription medicine containing Diclofenac and Misoprostol for oral use, marketed by Pfizer Laboratories, 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°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Diclofenac and Misoprostol
- Brand
- Arthrotec
- Strength
- 50 mg/200 mcg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 60 tablets, 90 tablets
- Marketing authorisation holder
- Pfizer Laboratories
- Manufacturer
- Pfizer Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F 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
- 24 December 1997
- Identifiers
- RxCUI 857706, 1359105, 1359107 +1DailyMed set ID 600fe842-45d9-4d68-9ef2-456dbbebaa11NDC 0025-1411Application NDA020607
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet, film coated in 1 bottle | 0025-1411-60 | Pfizer Laboratories | 24 December 1997 |
| 90 tablet, film coated in 1 bottle | 0025-1411-90 | Pfizer Laboratories | 24 December 1997 |
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
Alternatives
Other makers and brands of Diclofenac and Misoprostol 50 mg/200 mcg tablet.
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 Arthrotec 50 mg/200 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.