Medicine
Fluvastatin 80 mg extended-release tablet
Fluvastatin 80 mg extended-release tablet is a generic prescription medicine for oral use, made by 3 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 and Dispense Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted…
Key facts
- Active ingredient (INN)
- Fluvastatin
- Brand
- Sold under the generic name
- Strength
- 80 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets and 3 more
- Manufacturers
- LannettSandozTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store and Dispense Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to15ºC 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
- 16 October 2015
- Identifiers
- RxCUI 360507DailyMed set ID 3565bfd3-ef9f-456d-b4be-a294a7a0f01c, cc55110f-1ad6-4f97-840d-62b3a5ac415a, 5ab4296c-87c2-4c64-b218-d620eef51310NDC 0527-2580, 0093-7446, 0781-8017Application ANDA209397, ANDA079011, 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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated, extended release in 1 bottle, plastic | 0527-2580-32 | Lannett | 7 May 2021 |
| 100 tablet, film coated, extended release in 1 bottle, plastic | 0527-2580-37 | Lannett | 14 March 2022 |
| 100 tablet, extended release in 1 bottle | 0781-8017-01 | Sandoz | 2 May 2018 |
| 30 tablet, extended release in 1 bottle | 0781-8017-31 | Sandoz | 2 May 2018 |
| 100 tablet, film coated, extended release in 1 bottle | 0093-7446-01 | Teva Pharmaceuticals | 2 June 2016 |
| 30 tablet, film coated, extended release in 1 bottle | 0093-7446-56 | Teva Pharmaceuticals | 2 June 2016 |
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 Fluvastatin 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.