Medicine
Ezetimibe and Simvastatin 10 mg/20 mg tablet
Ezetimibe and Simvastatin 10 mg/20 mg tablet is a generic prescription medicine for oral use, made by 5 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).
Key facts
- Active ingredient (INN)
- Ezetimibe and Simvastatin
- Brand
- Sold under the generic name
- Strength
- 10 mg/20 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1000 tablets, 30 tablets, 10 blister pack and 11 more
- Manufacturers
- Ascend LaboratoriesIndiaDr. Reddy's LaboratoriesIndiaGlenmark PharmaceuticalsIndiaAurobindo PharmaIndiaGolden State Medical Supply
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10BA02 Ezetimibe and Simvastatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 April 2017
- Identifiers
- RxCUI 476345, 476349, 476350 +1DailyMed set ID 79dadfde-35c7-4937-9c82-1728fb6be2fb, 023ca87a-1b04-8c17-dc4f-e2758b0771e2, 88cd0e7b-e8dc-6125-e053-2a95a90aaa27 +2NDC 59651-836, 43598-744, 51407-191 +2Application ANDA200082, ANDA200909, ANDA209222 +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 |
|---|---|---|---|
| 1000 tablet in 1 bottle | 67877-508-01 | Ascend LaboratoriesIndia | 24 December 2017 |
| 30 tablet in 1 bottle | 67877-508-30 | Ascend LaboratoriesIndia | 24 December 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 67877-508-38 | Ascend LaboratoriesIndia | 24 December 2017 |
| 90 tablet in 1 bottle | 67877-508-90 | Ascend LaboratoriesIndia | 24 December 2017 |
| 30 tablet in 1 bottle | 59651-836-30 | Aurobindo PharmaIndia | 1 March 2024 |
| 90 tablet in 1 bottle | 59651-836-90 | Aurobindo PharmaIndia | 1 March 2024 |
| 1000 tablet in 1 bottle | 43598-744-10 | Dr. Reddy's LaboratoriesIndia | 20 November 2018 |
| 30 tablet in 1 bottle | 43598-744-30 | Dr. Reddy's LaboratoriesIndia | 20 November 2018 |
| 90 tablet in 1 bottle | 43598-744-90 | Dr. Reddy's LaboratoriesIndia | 20 November 2018 |
| 1000 tablet in 1 bottle | 68462-322-10 | Glenmark PharmaceuticalsIndia | 27 June 2019 |
| 30 tablet in 1 bottle | 68462-322-30 | Glenmark PharmaceuticalsIndia | 27 June 2019 |
| 90 tablet in 1 bottle | 68462-322-90 | Glenmark PharmaceuticalsIndia | 27 June 2019 |
| 1000 tablet in 1 bottle | 51407-191-10 | Golden State Medical Supply | 29 April 2019 |
| 90 tablet in 1 bottle | 51407-191-90 | Golden State Medical Supply | 29 April 2019 |
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 23 July 2004 | 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
Alternatives
Other makers and brands of Ezetimibe and Simvastatin 10 mg/20 mg tablet.
Other strengths and forms of Ezetimibe and Simvastatin
Clinical summary
Ezetimibe and Simvastatin is a fixed-dose combination of a dietary cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor indicated as an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C). MedsAcross supplies Ezetimibe and Simvastatin 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 Ezetimibe and SimvastatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VYTORIN prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Ezetimibe and Simvastatin 10 mg/20 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.