Medicine
Ranolazine 500 mg extended-release tablet
Ranolazine 500 mg extended-release tablet is a generic prescription medicine for oral use, made by 27 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 Ranolazine Extended-Release Tablets at 25°C (77°F) with excursions…
Key facts
- Active ingredient (INN)
- Ranolazine
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets, 500 tablets, 1000 tablets and 52 more
- Manufacturers
- Viona PharmaceuticalsIndiaZydus LifesciencesIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaUnichem LaboratoriesIndiaAjanta PharmaIndiaGlenmark PharmaceuticalsIndiaUmedica LaboratoriesIndiaCamber PharmaceuticalsIndiaLifestar PharmaIndia27 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store Ranolazine Extended-Release Tablets at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01EB18 Ranolazine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 February 2019
- Identifiers
- RxCUI 616749, 728231DailyMed set ID 9199e28a-ddbe-46a4-ab26-9b08034289be, abb32182-46ba-49d2-b2ac-13de2ecf802d, 45236b7d-3728-1e13-e063-6394a90ad77f +27NDC 71335-2556, 71610-518, 71610-971 +27Application ANDA213517, ANDA212781, ANDA211829 +12
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 27 labelers. The register lists 55 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet, extended release in 1 bottle | 27241-125-02 | Ajanta PharmaIndia | 23 August 2019 |
| 500 tablet, extended release in 1 bottle | 27241-125-05 | Ajanta PharmaIndia | 14 July 2021 |
| 1000 tablet, film coated, extended release in 1 bottle | 67877-525-10 | Ascend LaboratoriesIndia | 2 December 2020 |
| 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack | 67877-525-38 | Ascend LaboratoriesIndia | 2 December 2020 |
| 60 tablet, film coated, extended release in 1 bottle | 67877-525-60 | Ascend LaboratoriesIndia | 2 December 2020 |
| 180 tablet, film coated, extended release in 1 bottle | 59651-009-18 | Aurobindo PharmaIndia | 23 December 2022 |
| 60 tablet, film coated, extended release in 1 bottle | 59651-009-60 | Aurobindo PharmaIndia | 23 December 2022 |
| 1000 tablet, film coated, extended release in 1 bottle | 59651-009-99 | Aurobindo PharmaIndia | 23 December 2022 |
| 60 tablet, film coated, extended release in 1 bottle | 31722-668-60 | Camber PharmaceuticalsIndia | 5 May 2022 |
| 500 tablet, film coated, extended release in 1 bottle | 68462-319-05 | Glenmark PharmaceuticalsIndia | 5 July 2019 |
| 60 tablet, film coated, extended release in 1 bottle | 68462-319-60 | Glenmark PharmaceuticalsIndia | 5 July 2019 |
| 60 tablet, film coated, extended release in 1 bottle | 70756-703-60 | Lifestar PharmaIndia | 1 April 2020 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 13668-759-60 | Torrent PharmaceuticalsIndia | 11 May 2026 |
| 60 tablet, extended release in 1 bottle | 60290-055-01 | Umedica LaboratoriesIndia | 10 August 2026 |
| 6 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 60290-055-03 | Umedica LaboratoriesIndia | 10 August 2026 |
| 100 tablet, film coated, extended release in 1 bottle, plastic | 29300-296-01 | Unichem LaboratoriesIndia | 15 July 2023 |
| 500 tablet, film coated, extended release in 1 bottle, plastic | 29300-296-05 | Unichem LaboratoriesIndia | 15 July 2023 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 29300-296-16 | Unichem LaboratoriesIndia | 15 July 2023 |
| 100 tablet, extended release in 1 bottle | 72578-064-01 | Viona PharmaceuticalsIndia | 10 September 2019 |
| 500 tablet, extended release in 1 bottle | 72578-064-05 | Viona PharmaceuticalsIndia | 10 September 2019 |
| 60 tablet, extended release in 1 bottle | 72578-064-14 | Viona PharmaceuticalsIndia | 10 September 2019 |
| 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 72578-064-77 | Viona PharmaceuticalsIndia | 10 September 2019 |
| 100 tablet, extended release in 1 bottle | 70771-1499-1 | Zydus LifesciencesIndia | 10 September 2019 |
| 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 70771-1499-4 | Zydus LifesciencesIndia | 10 September 2019 |
| 500 tablet, extended release in 1 bottle | 70771-1499-5 | Zydus LifesciencesIndia | 10 September 2019 |
| 60 tablet, extended release in 1 bottle | 70771-1499-6 | Zydus LifesciencesIndia | 10 September 2019 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 73141-021-02 | A2A Integrated Pharmaceuticals | 8 April 2025 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 72319-021-02 | i3 Pharmaceuticals | 15 June 2022 |
| 60 tablet, film coated, extended release in 1 package | 77771-423-60 | Radha Pharmaceuticals | 30 June 2025 |
| 500 tablet, film coated, extended release in 1 package | 50228-423-05 | ScieGen Pharmaceuticals | 4 June 2019 |
| 30 tablet, film coated, extended release in 1 package | 50228-423-30 | ScieGen Pharmaceuticals | 4 June 2019 |
| 60 tablet, film coated, extended release in 1 package | 50228-423-60 | ScieGen Pharmaceuticals | 4 June 2019 |
| 29125 tablet, film coated, extended release in 1 box | 70625-206-00 | SunGen Pharma | 1 April 2020 |
| 60 tablet, film coated, extended release in 1 bottle | 70625-206-01 | SunGen Pharma | 1 April 2020 |
| 500 tablet, film coated, extended release in 1 bottle | 70625-206-02 | SunGen Pharma | 1 April 2020 |
| 60 tablet, film coated, extended release in 1 bottle | 90096-151-60 | Zameer Pharmaceuticals | 22 April 2026 |
| 1800 tablet, film coated, extended release in 1 bottle | 71610-518-42 | Aphena Pharma Solutions - Tennessee | 1 April 2024 |
| 3600 tablet, film coated, extended release in 1 bottle | 71610-518-83 | Aphena Pharma Solutions - Tennessee | 22 January 2021 |
| 1800 tablet, film coated, extended release in 1 bottle | 71610-971-42 | Aphena Pharma Solutions - Tennessee | 3 December 2025 |
| 60 tablet, extended release in 1 bottle | 63629-4874-1 | Bryant Ranch Prepack | 17 January 2025 |
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.
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 Ranolazine
Clinical summary
Ranolazine is an anti-anginal indicated for the treatment of chronic angina. It is available as extended-release tablets and granules for oral use. MedsAcross supplies Ranolazine 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 RanolazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ASPRUZYO SPRINKLE prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
- Ranexa (previously Latixa): European public assessment report (EPAR) · European Medicines Agency
Need Ranolazine 500 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.