Medicine
Etodolac 400 mg extended-release tablet
Etodolac 400 mg extended-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°C to 25°C (68°F to 77°F). Protect from excessive heat and humidity.
Key facts
- Active ingredient (INN)
- Etodolac
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 28 more
- Manufacturers
- Zydus LifesciencesIndiaProficient RxTaSun Pharmaceutical IndustriesNorthStar RxGolden State Medical SupplyNuCare Pharmaceuticals,IncTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Protect from excessive heat and humidity.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M01AB08 Etodolac
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 February 2001
- Identifiers
- RxCUI 310245, 310247, 359500DailyMed set ID 7ef79e43-0628-4795-937e-ebb752d79133, c59c5108-a09b-2a03-e053-2995a90abba1, 4712e069-83b6-4052-8d95-f59ab1dba744 +7NDC 68382-271, 60429-313, 63187-374 +7Application ANDA091134, ANDA076174, ANDA075665
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 | 65841-777-01 | Zydus LifesciencesIndia | 15 February 2014 |
| 500 tablet, film coated, extended release in 1 bottle | 65841-777-05 | Zydus LifesciencesIndia | 15 February 2014 |
| 1000 tablet, film coated, extended release in 1 bottle | 65841-777-10 | Zydus LifesciencesIndia | 15 February 2014 |
| 60 tablet, film coated, extended release in 1 bottle | 65841-777-14 | Zydus LifesciencesIndia | 15 February 2014 |
| 100 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack | 65841-777-77 | Zydus LifesciencesIndia | 15 February 2014 |
| 100 tablet, film coated, extended release in 1 bottle | 68382-271-01 | Zydus LifesciencesIndia | 15 February 2014 |
| 500 tablet, film coated, extended release in 1 bottle | 68382-271-05 | Zydus LifesciencesIndia | 15 February 2014 |
| 1000 tablet, film coated, extended release in 1 bottle | 68382-271-10 | Zydus LifesciencesIndia | 15 February 2014 |
| 60 tablet, film coated, extended release in 1 bottle | 68382-271-14 | Zydus LifesciencesIndia | 15 February 2014 |
| 100 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack | 68382-271-77 | Zydus LifesciencesIndia | 15 February 2014 |
| 100 tablet, extended release in 1 bottle | 51672-4051-1 | TaSun Pharmaceutical Industries | 13 March 2003 |
| 500 tablet, extended release in 1 bottle | 51672-4051-2 | TaSun Pharmaceutical Industries | 13 March 2003 |
| 1000 tablet, extended release in 1 bottle | 51672-4051-3 | TaSun Pharmaceutical Industries | 13 March 2003 |
| 60 tablet, extended release in 1 bottle | 51672-4051-4 | TaSun Pharmaceutical Industries | 13 March 2003 |
| 30 tablet, extended release in 1 bottle | 51672-4051-6 | TaSun Pharmaceutical Industries | 13 March 2003 |
| 10 blister pack in 1 carton / 6 tablet, extended release in 1 blister pack | 51672-4051-9 | TaSun Pharmaceutical Industries | 13 March 2003 |
| 100 tablet, film coated, extended release in 1 bottle | 0093-1122-01 | Teva Pharmaceuticals | 9 February 2001 |
| 30 tablet, film coated, extended release in 1 bottle | 63187-374-30 | Proficient Rx | 1 September 2016 |
| 60 tablet, film coated, extended release in 1 bottle | 63187-374-60 | Proficient Rx | 1 September 2016 |
| 90 tablet, film coated, extended release in 1 bottle | 63187-374-90 | Proficient Rx | 1 September 2016 |
| 20 tablet, extended release in 1 bottle | 63187-793-20 | Proficient Rx | 1 December 2016 |
| 30 tablet, extended release in 1 bottle | 63187-793-30 | Proficient Rx | 1 December 2016 |
| 60 tablet, extended release in 1 bottle | 63187-793-60 | Proficient Rx | 1 December 2016 |
| 90 tablet, extended release in 1 bottle | 63187-793-90 | Proficient Rx | 1 December 2016 |
| 30 tablet, film coated, extended release in 1 bottle | 71205-140-30 | Proficient Rx | 31 October 2018 |
| 60 tablet, film coated, extended release in 1 bottle | 71205-140-60 | Proficient Rx | 31 October 2018 |
| 90 tablet, film coated, extended release in 1 bottle | 71205-140-90 | Proficient Rx | 31 October 2018 |
| 100 tablet, extended release in 1 bottle | 60429-313-01 | Golden State Medical Supply | 18 July 2011 |
| 60 tablet, extended release in 1 bottle | 16714-497-01 | Northstar RX | 15 August 2016 |
| 100 tablet, extended release in 1 bottle | 16714-497-02 | Northstar RX | 15 August 2016 |
| 14 tablet, film coated, extended release in 1 bottle | 68071-3731-4 | NuCare Pharmaceuticals | 27 November 2024 |
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 31 January 1991 | 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 Etodolac
Clinical summary
Etodolac is a nonsteroidal anti-inflammatory drug indicated for acute and long-term use in the management of signs and symptoms of the following. It is available as tablets, extended-release tablets and capsules for oral use. MedsAcross supplies Etodolac 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 EtodolacFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Etodolac prescribing information (Apotex) · U.S. National Library of Medicine, DailyMed
Need Etodolac 400 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.