Medicine
Etodolac 500 mg tablet
Etodolac 500 mg tablet is a generic prescription medicine for oral use, made by 17 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° to 25°C (68° to 77°F). Protect from moisture. Store tablets in…
Key facts
- Active ingredient (INN)
- Etodolac
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 36 more
- Manufacturers
- Ipca LaboratoriesIndiaAurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackA-S Medication SolutionsProficient RxAphena Pharma Solutions - TennesseeRemedyrepackAmneal Pharmaceuticals NY
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from moisture. Store tablets in original container until ready to use.
- 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
- 25 April 2000
- Identifiers
- RxCUI 199390, 197684, 197685 +1DailyMed set ID 4b0d1245-8d01-4fff-9783-cb30c17d9246, 12f0685b-2127-d0d6-e063-6394a90a62d1, cf17926c-ed90-4fd0-80af-ccee084075e8 +19NDC 71335-1230, 45865-206, 60429-312 +19Application ANDA208834, ANDA076004, ANDA075074 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 59651-462-01 | Aurobindo PharmaIndia | 15 July 2026 |
| 100 tablet in 1 bottle | 83980-030-01 | Ipca LaboratoriesIndia | 13 February 2026 |
| 500 tablet in 1 bottle | 83980-030-05 | Ipca LaboratoriesIndia | 13 February 2026 |
| 30 tablet in 1 bottle | 83980-030-13 | Ipca LaboratoriesIndia | 13 February 2026 |
| 100 tablet, film coated in 1 bottle | 51672-4036-1 | Sun Pharmaceutical IndustriesIndia | 25 April 2000 |
| 100 tablet, film coated in 1 bottle | 76385-119-01 | Unichem LaboratoriesIndia | 1 August 2021 |
| 100 tablet, film coated in 1 bottle | 69238-1343-1 | Amneal Pharmaceuticals NY | 11 June 2018 |
| 100 tablet, film coated in 1 bottle | 60505-0102-1 | Apotex | 1 May 2003 |
| 60 tablet, film coated in 1 bottle | 62135-911-60 | Chartwell RX | 29 August 2024 |
| 100 tablet, film coated in 1 bottle | 42799-112-01 | Edenbridge Pharmaceuticals | 7 December 2018 |
| 60 tablet, film coated in 1 bottle | 50090-1489-5 | A-S Medication Solutions | 4 December 2014 |
| 20 tablet, film coated in 1 bottle | 50090-3974-0 | A-S Medication Solutions | 13 December 2018 |
| 60 tablet, film coated in 1 bottle | 50090-3974-5 | A-S Medication Solutions | 13 December 2018 |
| 60 tablet, film coated in 1 bottle | 50090-6739-5 | A-S Medication Solutions | 12 October 2023 |
| 60 tablet, film coated in 1 bottle | 71610-779-53 | Aphena Pharma Solutions - Tennessee | 25 January 2024 |
| 60 tablet, film coated in 1 bottle | 71610-795-53 | Aphena Pharma Solutions - Tennessee | 12 February 2024 |
| 60 tablet, film coated in 1 bottle | 71335-0399-1 | Bryant Ranch Prepack | 5 September 2024 |
| 90 tablet, film coated in 1 bottle | 71335-0399-2 | Bryant Ranch Prepack | 5 September 2024 |
| 30 tablet, film coated in 1 bottle | 71335-0399-3 | Bryant Ranch Prepack | 5 September 2024 |
| 100 tablet, film coated in 1 bottle | 71335-0399-4 | Bryant Ranch Prepack | 5 September 2024 |
| 6 tablet, film coated in 1 bottle | 71335-0399-5 | Bryant Ranch Prepack | 5 September 2024 |
| 20 tablet, film coated in 1 bottle | 71335-0399-6 | Bryant Ranch Prepack | 5 September 2024 |
| 14 tablet, film coated in 1 bottle | 71335-0399-7 | Bryant Ranch Prepack | 5 September 2024 |
| 60 tablet, film coated in 1 bottle | 71335-1230-1 | Bryant Ranch Prepack | 28 May 2019 |
| 90 tablet, film coated in 1 bottle | 71335-1230-2 | Bryant Ranch Prepack | 17 May 2024 |
| 30 tablet, film coated in 1 bottle | 71335-1230-3 | Bryant Ranch Prepack | 17 May 2024 |
| 100 tablet, film coated in 1 bottle | 71335-1230-4 | Bryant Ranch Prepack | 17 May 2024 |
| 6 tablet, film coated in 1 bottle | 71335-1230-5 | Bryant Ranch Prepack | 17 May 2024 |
| 20 tablet, film coated in 1 bottle | 71335-1230-6 | Bryant Ranch Prepack | 17 May 2024 |
| 14 tablet, film coated in 1 bottle | 71335-1230-7 | Bryant Ranch Prepack | 17 May 2024 |
| 60 tablet, film coated in 1 bottle, plastic | 70518-3845-0 | Remedyrepack | 30 August 2023 |
| 60 tablet, film coated in 1 bottle, plastic | 70518-4291-0 | Remedyrepack | 25 February 2025 |
| 100 tablet, film coated in 1 bottle | 60429-312-01 | Golden State Medical Supply | 18 July 2011 |
| 30 tablet, film coated in 1 bottle | 45865-206-30 | Medsource Pharmaceuticals | 14 December 2022 |
| 30 tablet, film coated in 1 bottle, plastic | 51655-735-52 | Northwind Health | 8 July 2021 |
| 30 tablet, film coated in 1 bottle, plastic | 43063-671-30 | PD-Rx Pharmaceuticals | 16 January 2018 |
| 30 tablet, film coated in 1 bottle | 71205-467-30 | Proficient Rx | 20 August 2020 |
| 60 tablet, film coated in 1 bottle | 71205-467-60 | Proficient Rx | 20 August 2020 |
| 90 tablet, film coated in 1 bottle | 71205-467-90 | Proficient Rx | 20 August 2020 |
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 500 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.