Medicine
Lescol XL 80 mg extended-release tablet
Lescol XL 80 mg extended-release tablet is a prescription medicine containing Fluvastatin for oral use, marketed by Sandoz, 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 and Dispense Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted…
Key facts
- Active ingredient (INN)
- Fluvastatin
- Brand
- Lescol XL
- Strength
- 80 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Sandoz
- Manufacturer
- Sandoz
- Origin register
- US FDA, United States
- Storage
- Store and Dispense Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC to 30ºC (59ºF to 86ºF). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AA04 Fluvastatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 October 2000
- Identifiers
- RxCUI 360507, 687048DailyMed set ID 726ea2db-f1b0-4b73-a515-02157db88a42NDC 66758-211Application NDA021192
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, extended release in 1 bottle | 66758-211-31 | Sandoz | 2 August 2024 |
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 December 1993 | 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 Fluvastatin 80 mg extended-release tablet.
Other strengths and forms of Fluvastatin
Clinical summary
Fluvastatin is an HMG-CoA reductase inhibitor indicated to reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease, among other approved uses. MedsAcross supplies Fluvastatin 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 FluvastatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FLUVASTATIN SODIUM ER prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Lescol XL 80 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.