Medicine
Zipsor 25 mg capsule
Zipsor 25 mg capsule is a prescription medicine containing Diclofenac for oral use, marketed by Assertio Specialty Pharmaceuticals, 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 room temperature 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Zipsor
- Strength
- 25 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 120 capsules
- Marketing authorisation holder
- Assertio Specialty Pharmaceuticals
- Manufacturers
- Assertio Specialty PharmaceuticalsAssertio Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from moisture Dispense in tight container (USP).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D11AX18 Diclofenac
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 June 2009
- Identifiers
- RxCUI 858342, 858346DailyMed set ID c982eca0-fc41-11e1-a9c8-0002a5d5c51b, ed2a8868-78eb-47b8-8f46-0f70e2891e07NDC 13913-008, 82497-008Application NDA022202
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 |
|---|---|---|---|
| 120 capsule, liquid filled in 1 bottle | 82497-008-12 | Assertio Specialty Pharmaceuticals | 24 August 2026 |
| 120 capsule, liquid filled in 1 bottle | 13913-008-12 | Assertio Therapeutics | 1 December 2015 |
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 28 July 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 Diclofenac 25 mg capsule.
Other strengths and forms of Diclofenac
Clinical summary
Diclofenac is a nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. MedsAcross supplies Diclofenac 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 DiclofenacFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZIPSOR prescribing information (Assertio Specialty Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Zipsor 25 mg capsule 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.