Medicine
Ezetimibe 10 mg tablet
Ezetimibe 10 mg tablet is a generic prescription medicine for oral use, made by 22 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 25°C (77°F), excursions permitted between 15 to 30°C (59 to 86°F)…
Key facts
- Active ingredient (INN)
- Ezetimibe
- Brand
- Sold under the generic name
- Strength
- 10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 120 more
- Manufacturers
- Zydus LifesciencesIndiaCamber PharmaceuticalsIndiaAscend LaboratoriesIndiaGlenmark PharmaceuticalsIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaOhm LaboratoriesIndiaAccord HealthcareIndiaAmneal Pharmaceuticals NY22 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted between 15 to 30°C (59 to 86°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AX09 Ezetimibe
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 June 2017
- Identifiers
- RxCUI 349556DailyMed set ID 9a04678f-e961-45aa-b3bb-e38e66856edc, a1cc2018-72a3-48bc-90de-c460f224cf5a, 5b3842f6-c80a-47b8-8a82-b69e465b05f7 +37NDC 50090-3657, 50090-6631, 51660-200 +37Application ANDA209234, ANDA209838, ANDA207311 +10
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 22 labelers. The register lists 123 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 68382-773-01 | Zydus LifesciencesIndia | 9 August 2017 |
| 500 tablet in 1 bottle | 68382-773-05 | Zydus LifesciencesIndia | 9 August 2017 |
| 30 tablet in 1 bottle | 68382-773-06 | Zydus LifesciencesIndia | 9 August 2017 |
| 1000 tablet in 1 bottle | 68382-773-10 | Zydus LifesciencesIndia | 9 August 2017 |
| 90 tablet in 1 bottle | 68382-773-16 | Zydus LifesciencesIndia | 9 August 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 68382-773-77 | Zydus LifesciencesIndia | 9 August 2017 |
| 1000 tablet in 1 bottle | 70771-1109-0 | Zydus LifesciencesIndia | 9 August 2017 |
| 100 tablet in 1 bottle | 70771-1109-1 | Zydus LifesciencesIndia | 9 August 2017 |
| 30 tablet in 1 bottle | 70771-1109-3 | Zydus LifesciencesIndia | 9 August 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1109-4 | Zydus LifesciencesIndia | 9 August 2017 |
| 500 tablet in 1 bottle | 70771-1109-5 | Zydus LifesciencesIndia | 9 August 2017 |
| 90 tablet in 1 bottle | 70771-1109-9 | Zydus LifesciencesIndia | 9 August 2017 |
| 30 tablet in 1 bottle | 16729-433-10 | Accord HealthcareIndia | 1 November 2019 |
| 100 tablet in 1 bottle | 67877-490-01 | Ascend LaboratoriesIndia | 23 December 2017 |
| 500 tablet in 1 bottle | 67877-490-05 | Ascend LaboratoriesIndia | 23 December 2017 |
| 30 tablet in 1 bottle | 67877-490-30 | Ascend LaboratoriesIndia | 23 December 2017 |
| 5000 tablet in 1 bottle | 67877-490-55 | Ascend LaboratoriesIndia | 23 December 2017 |
| 90 tablet in 1 bottle | 67877-490-90 | Ascend LaboratoriesIndia | 23 December 2017 |
| 500 tablet in 1 bottle | 59651-052-05 | Aurobindo PharmaIndia | 25 August 2017 |
| 30 tablet in 1 bottle | 59651-052-30 | Aurobindo PharmaIndia | 25 August 2017 |
| 90 tablet in 1 bottle | 59651-052-90 | Aurobindo PharmaIndia | 25 August 2017 |
| 100 tablet in 1 bottle | 31722-628-01 | Camber PharmaceuticalsIndia | 26 July 2022 |
| 500 tablet in 1 bottle | 31722-628-05 | Camber PharmaceuticalsIndia | 25 September 2023 |
| 1000 tablet in 1 bottle | 31722-628-10 | Camber PharmaceuticalsIndia | 25 September 2023 |
| 30 tablet in 1 bottle | 31722-628-30 | Camber PharmaceuticalsIndia | 26 July 2022 |
| 100 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-628-31 | Camber PharmaceuticalsIndia | 26 July 2022 |
| 100 blister pack in 1 carton / 10 tablet in 1 blister pack | 31722-628-34 | Camber PharmaceuticalsIndia | 26 July 2022 |
| 90 tablet in 1 bottle | 31722-628-90 | Camber PharmaceuticalsIndia | 26 July 2022 |
| 500 tablet in 1 bottle | 68462-226-05 | Glenmark PharmaceuticalsIndia | 29 April 2022 |
| 1000 tablet in 1 bottle | 68462-226-10 | Glenmark PharmaceuticalsIndia | 29 April 2022 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 68462-226-11 | Glenmark PharmaceuticalsIndia | 29 April 2022 |
| 30 tablet in 1 bottle | 68462-226-30 | Glenmark PharmaceuticalsIndia | 29 April 2022 |
| 90 tablet in 1 bottle | 68462-226-90 | Glenmark PharmaceuticalsIndia | 29 April 2022 |
| 30 tablet in 1 bottle | 33342-373-07 | Macleods PharmaceuticalsIndia | 29 April 2024 |
| 90 tablet in 1 bottle | 33342-373-10 | Macleods PharmaceuticalsIndia | 29 April 2024 |
| 500 tablet in 1 bottle | 33342-373-15 | Macleods PharmaceuticalsIndia | 29 April 2024 |
| 500 tablet in 1 bottle | 51660-200-05 | Ohm LaboratoriesIndia | 12 June 2017 |
| 30 tablet in 1 bottle | 51660-200-30 | Ohm LaboratoriesIndia | 12 June 2017 |
| 90 tablet in 1 bottle | 51660-200-90 | Ohm LaboratoriesIndia | 12 June 2017 |
| 1000 tablet in 1 bottle | 69238-1154-1 | Amneal Pharmaceuticals NY | 12 June 2017 |
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 25 October 2002 | 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 10 mg tablet.
Clinical summary
Ezetimibe is a dietary cholesterol absorption inhibitor indicated in combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, among other approved uses. MedsAcross supplies Ezetimibe 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 EzetimibeFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zetia prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Ezetimibe 10 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.