Medicine
Etodolac 300 mg capsule
Etodolac 300 mg capsule is a generic prescription medicine for oral use, made by 8 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). protected from moisture.
Key facts
- Active ingredient (INN)
- Etodolac
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules, 30 capsules and 9 more
- Manufacturers
- Ipca LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaA-S Medication SolutionsBryant Ranch PrepackANI PharmaceuticalsApotexGolden State Medical SupplyNorthwind Health
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). protected from moisture.
- 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
- 30 April 1998
- Identifiers
- RxCUI 197685, 197684, 197686 +1DailyMed set ID 1e04a6b7-a671-4999-ab03-aa1a243aac03, d583988c-3e7e-4415-b2fd-34049791cd1c, cf17926c-ed90-4fd0-80af-ccee084075e8 +7NDC 50090-8037, 83980-032, 60429-244 +7Application ANDA205448, ANDA075078, ANDA075419 +1
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 capsule in 1 bottle | 83980-032-01 | Ipca LaboratoriesIndia | 6 February 2026 |
| 500 capsule in 1 bottle | 83980-032-05 | Ipca LaboratoriesIndia | 6 February 2026 |
| 30 capsule in 1 bottle | 83980-032-13 | Ipca LaboratoriesIndia | 6 February 2026 |
| 100 capsule in 1 bottle | 51672-4017-1 | Sun Pharmaceutical IndustriesIndia | 30 April 1998 |
| 100 capsule in 1 bottle | 62559-251-01 | ANI Pharmaceuticals | 1 February 2015 |
| 100 capsule in 1 bottle | 60505-0040-1 | Apotex | 1 May 2003 |
| 21 capsule in 1 bottle | 50090-2132-1 | A-S Medication Solutions | 15 October 2015 |
| 21 capsule in 1 bottle | 50090-8037-1 | A-S Medication Solutions | 25 August 2026 |
| 100 capsule in 1 bottle | 63629-1936-1 | Bryant Ranch Prepack | 29 June 2021 |
| 100 capsule in 1 bottle | 72162-1757-1 | Bryant Ranch Prepack | 25 March 2026 |
| 100 capsule in 1 bottle | 60429-244-01 | Golden State Medical Supply | 18 July 2011 |
| 30 capsule in 1 bottle, dispensing | 51655-166-52 | Northwind Health | 13 November 2014 |
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 300 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.