Medicine
Diclofenac 100 mg extended-release tablet
Diclofenac 100 mg extended-release tablet is a generic prescription medicine for oral use, made by 9 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F)…
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 7 tablets, 30 tablets and 21 more
- Manufacturers
- Aurobindo PharmaIndiaBryant Ranch PrepackProficient RxNuCare Pharmaceuticals,IncA-S Medication SolutionsAdvanced Rx Pharmacy of TennesseeEdenbridge PharmaceuticalsOceanside PharmaceuticalsSt. Mary's Medical Park Pharmacy
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture.
- 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
- 28 February 2000
- Identifiers
- RxCUI 855657DailyMed set ID d70fcd8e-a72b-41ef-ac26-e0f2f279f062, 0d1d19e5-4ffe-af95-e063-6394a90a7abf, c48113e0-9f1e-4086-b18f-3204c0d2a689 +8NDC 63187-994, 68071-3556, 68682-103 +8Application ANDA075492, ANDA076201, ANDA076152
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 |
|---|---|---|---|
| 100 tablet, film coated, extended release in 1 bottle | 84386-103-01 | Aurobindo PharmaIndia | 16 July 2026 |
| 100 tablet, extended release in 1 bottle | 42799-953-01 | Edenbridge Pharmaceuticals | 14 June 2023 |
| 100 tablet, film coated, extended release in 1 bottle | 68682-103-01 | Oceanside Pharmaceuticals | 28 February 2000 |
| 7 tablet, film coated, extended release in 1 bottle | 68071-2223-7 | NuCare Pharmaceuticals,Inc | 30 July 2020 |
| 7 tablet, extended release in 1 bottle, plastic | 68071-3556-7 | NuCare Pharmaceuticals,Inc | 22 December 2023 |
| 30 tablet, extended release in 1 bottle | 68071-3720-3 | NuCare Pharmaceuticals | 6 November 2026 |
| 7 tablet, extended release in 1 bottle | 68071-3720-7 | NuCare Pharmaceuticals | 14 November 2024 |
| 30 tablet, film coated, extended release in 1 bottle | 50090-4172-1 | A-S Medication Solutions | 7 March 2019 |
| 30 tablet, film coated, extended release in 1 bottle | 80425-0210-1 | Advanced Rx Pharmacy of Tennessee | 4 November 2023 |
| 60 tablet, film coated, extended release in 1 bottle | 71335-0648-1 | Bryant Ranch Prepack | 22 May 2018 |
| 30 tablet, film coated, extended release in 1 bottle | 71335-0648-2 | Bryant Ranch Prepack | 13 April 2018 |
| 15 tablet, film coated, extended release in 1 bottle | 71335-0648-3 | Bryant Ranch Prepack | 29 January 2025 |
| 14 tablet, film coated, extended release in 1 bottle | 71335-0648-4 | Bryant Ranch Prepack | 23 July 2018 |
| 10 tablet, film coated, extended release in 1 bottle | 71335-0648-5 | Bryant Ranch Prepack | 13 October 2022 |
| 21 tablet, film coated, extended release in 1 bottle | 71335-0648-6 | Bryant Ranch Prepack | 3 July 2018 |
| 90 tablet, film coated, extended release in 1 bottle | 71335-0648-7 | Bryant Ranch Prepack | 16 April 2019 |
| 120 tablet, film coated, extended release in 1 bottle | 71335-0648-8 | Bryant Ranch Prepack | 29 January 2025 |
| 7 tablet, film coated, extended release in 1 bottle | 71335-0648-9 | Bryant Ranch Prepack | 29 January 2025 |
| 15 tablet, film coated, extended release in 1 bottle | 63187-994-15 | Proficient Rx | 1 March 2018 |
| 20 tablet, film coated, extended release in 1 bottle | 63187-994-20 | Proficient Rx | 1 March 2018 |
| 30 tablet, film coated, extended release in 1 bottle | 63187-994-30 | Proficient Rx | 1 March 2018 |
| 60 tablet, film coated, extended release in 1 bottle | 63187-994-60 | Proficient Rx | 1 March 2018 |
| 90 tablet, film coated, extended release in 1 bottle | 63187-994-90 | Proficient Rx | 1 March 2018 |
| 30 tablet, extended release in 1 bottle, plastic | 60760-953-30 | ST. Mary's Medical Park Pharmacy | 18 March 2026 |
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
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 Diclofenac 100 mg extended-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.