Medicine
Etodolac 400 mg tablet
Etodolac 400 mg tablet is a generic prescription medicine for oral use, made by 21 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), excursions permitted from 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Etodolac
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 30 tablets and 91 more
- Manufacturers
- Ipca LaboratoriesIndiaAurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackAmneal Pharmaceuticals NYApotexChartwell RXDoc RxEdenbridge Pharmaceuticals21 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 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
- M01AB08 Etodolac
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 March 1998
- Identifiers
- RxCUI 197686, 199390, 197684 +1DailyMed set ID 141be3f6-198d-ce46-e063-6294a90a7993, bf1afcd5-e1da-4874-981f-f252cb0b32c2, 336d5331-4d60-42e2-8cfc-aad57c01eda0 +33NDC 71610-804, 42799-111, 50090-4053 +33Application ANDA076004, ANDA209888, ANDA208834 +4
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
A sample of 40 packs from 21 labelers. The register lists 94 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 59651-461-01 | Aurobindo PharmaIndia | 15 July 2026 |
| 100 tablet in 1 bottle | 83980-029-01 | Ipca LaboratoriesIndia | 13 February 2026 |
| 1000 tablet in 1 bottle | 83980-029-10 | Ipca LaboratoriesIndia | 13 February 2026 |
| 30 tablet in 1 bottle | 83980-029-13 | Ipca LaboratoriesIndia | 13 February 2026 |
| 100 tablet, film coated in 1 bottle | 51672-4018-1 | Sun Pharmaceutical IndustriesIndia | 11 March 1998 |
| 100 tablet, film coated in 1 bottle | 76385-118-01 | Unichem LaboratoriesIndia | 1 August 2021 |
| 100 tablet, film coated in 1 bottle | 69238-1342-1 | Amneal Pharmaceuticals NY | 11 June 2018 |
| 100 tablet, film coated in 1 bottle | 60505-0041-1 | Apotex | 1 May 2003 |
| 60 tablet, film coated in 1 bottle | 62135-910-60 | Chartwell RX | 29 August 2024 |
| 20 tablet, film coated in 1 bottle | 69306-020-40 | Doc Rx | 16 June 2021 |
| 100 tablet, film coated in 1 bottle | 42799-111-01 | Edenbridge Pharmaceuticals | 7 December 2018 |
| 100 tablet, film coated in 1 bottle | 63629-8805-1 | Bryant Ranch Prepack | 1 May 2003 |
| 20 tablet, film coated in 1 bottle | 71335-0126-1 | Bryant Ranch Prepack | 20 February 2018 |
| 14 tablet, film coated in 1 bottle | 71335-0126-2 | Bryant Ranch Prepack | 5 September 2024 |
| 30 tablet, film coated in 1 bottle | 71335-0126-3 | Bryant Ranch Prepack | 27 November 2018 |
| 100 tablet, film coated in 1 bottle | 71335-0126-4 | Bryant Ranch Prepack | 5 September 2024 |
| 60 tablet, film coated in 1 bottle | 71335-0126-5 | Bryant Ranch Prepack | 6 April 2018 |
| 90 tablet, film coated in 1 bottle | 71335-0126-6 | Bryant Ranch Prepack | 5 September 2024 |
| 56 tablet, film coated in 1 bottle | 71335-0126-7 | Bryant Ranch Prepack | 14 February 2018 |
| 120 tablet, film coated in 1 bottle | 71335-0126-8 | Bryant Ranch Prepack | 5 September 2024 |
| 20 tablet, film coated in 1 bottle | 71335-0982-1 | Bryant Ranch Prepack | 9 November 2018 |
| 14 tablet, film coated in 1 bottle | 71335-0982-2 | Bryant Ranch Prepack | 9 April 2024 |
| 30 tablet, film coated in 1 bottle | 71335-0982-3 | Bryant Ranch Prepack | 30 October 2018 |
| 100 tablet, film coated in 1 bottle | 71335-0982-4 | Bryant Ranch Prepack | 9 April 2024 |
| 60 tablet, film coated in 1 bottle | 71335-0982-5 | Bryant Ranch Prepack | 28 November 2018 |
| 90 tablet, film coated in 1 bottle | 71335-0982-6 | Bryant Ranch Prepack | 9 April 2024 |
| 56 tablet, film coated in 1 bottle | 71335-0982-7 | Bryant Ranch Prepack | 19 December 2018 |
| 120 tablet, film coated in 1 bottle | 71335-0982-8 | Bryant Ranch Prepack | 9 April 2024 |
| 20 tablet, film coated in 1 bottle | 71335-1958-1 | Bryant Ranch Prepack | 20 August 2026 |
| 14 tablet, film coated in 1 bottle | 71335-1958-2 | Bryant Ranch Prepack | 20 August 2026 |
| 30 tablet, film coated in 1 bottle | 71335-1958-3 | Bryant Ranch Prepack | 7 December 2021 |
| 100 tablet, film coated in 1 bottle | 71335-1958-4 | Bryant Ranch Prepack | 20 August 2026 |
| 60 tablet, film coated in 1 bottle | 71335-1958-5 | Bryant Ranch Prepack | 27 September 2021 |
| 90 tablet, film coated in 1 bottle | 71335-1958-6 | Bryant Ranch Prepack | 18 October 2021 |
| 56 tablet, film coated in 1 bottle | 71335-1958-7 | Bryant Ranch Prepack | 11 October 2021 |
| 120 tablet, film coated in 1 bottle | 71335-1958-8 | Bryant Ranch Prepack | 20 August 2026 |
| 20 tablet, film coated in 1 bottle | 71335-2259-1 | Bryant Ranch Prepack | 30 October 2023 |
| 14 tablet, film coated in 1 bottle | 71335-2259-2 | Bryant Ranch Prepack | 30 October 2023 |
| 30 tablet, film coated in 1 bottle | 71335-2259-3 | Bryant Ranch Prepack | 30 October 2023 |
| 100 tablet, film coated in 1 bottle | 71335-2259-4 | Bryant Ranch Prepack | 30 October 2023 |
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 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.