Zetia 10 mg tablet is a prescription medicine containing Ezetimibe for oral use, marketed by Organon, 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 ZETIA at room temperature between 68°F to 77°F (20°C to 25°C). Protect…
Key facts
- Active ingredient (INN)
- Ezetimibe
- Brand
- Zetia
- Strength
- 10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Organon
- Manufacturer
- Organon
- Origin register
- US FDA, United States
- Storage
- Store ZETIA at room temperature between 68°F to 77°F (20°C to 25°C). 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
- 1 June 2021
- Identifiers
- RxCUI 349556, 352304DailyMed set ID 174e45e0-45bb-48b7-9e60-8f6cfc1d22bbNDC 78206-178Application NDA021445
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle | 78206-178-01 | Organon | 1 June 2021 |
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 Zetia 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.