Medicine
Simvastatin 80 mg tablet
Simvastatin 80 mg tablet is a generic prescription medicine for oral use, made by 16 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)
- Simvastatin
- Brand
- Sold under the generic name
- Strength
- 80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 1000 tablets and 57 more
- Manufacturers
- Aurobindo PharmaIndiaBioconIndiaCamber PharmaceuticalsIndiaAccord HealthcareIndiaLupinIndiaA-S Medication SolutionsXLCare PharmaceuticalsBryant Ranch PrepackAphena Pharma Solutions - Tennessee16 labelers on the register
- 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
- C10AA01 Simvastatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 December 2006
- Identifiers
- RxCUI 198211, 200345, 312961 +2DailyMed set ID 2b4255a7-f9f5-4235-8dbb-b0f03acbd624, 02245025-218d-4297-aeb6-91fefa178291, 4724dbb4-3613-4e6a-948f-a43d34f97f06 +17NDC 82009-016, 50090-7783, 65862-054 +17Application ANDA200895, ANDA077691, ANDA078103 +3
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 16 labelers. The register lists 60 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 16729-007-10 | Accord HealthcareIndia | 26 February 2008 |
| 90 tablet, film coated in 1 bottle | 16729-007-15 | Accord HealthcareIndia | 26 February 2008 |
| 1000 tablet, film coated in 1 bottle | 16729-007-17 | Accord HealthcareIndia | 26 February 2008 |
| 100 tablet, film coated in 1 bottle | 65862-054-00 | Aurobindo PharmaIndia | 20 December 2006 |
| 30 tablet, film coated in 1 bottle | 65862-054-30 | Aurobindo PharmaIndia | 20 December 2006 |
| 3000 tablet, film coated in 1 bottle | 65862-054-39 | Aurobindo PharmaIndia | 20 December 2006 |
| 45 tablet, film coated in 1 bottle | 65862-054-45 | Aurobindo PharmaIndia | 20 December 2006 |
| 90 tablet, film coated in 1 bottle | 65862-054-90 | Aurobindo PharmaIndia | 20 December 2006 |
| 1000 tablet, film coated in 1 bottle | 65862-054-99 | Aurobindo PharmaIndia | 20 December 2006 |
| 30 tablet, film coated in 1 bottle | 70377-005-12 | BioconIndia | 17 December 2015 |
| 45 tablet, film coated in 1 bottle | 70377-005-13 | BioconIndia | 17 December 2015 |
| 90 tablet, film coated in 1 bottle | 70377-005-14 | BioconIndia | 17 December 2015 |
| 1000 tablet, film coated in 1 bottle | 70377-005-15 | BioconIndia | 17 December 2015 |
| 100 tablet, film coated in 1 bottle | 31722-514-01 | Camber PharmaceuticalsIndia | 9 December 2014 |
| 500 tablet, film coated in 1 bottle | 31722-514-05 | Camber PharmaceuticalsIndia | 9 December 2014 |
| 30 tablet, film coated in 1 bottle | 31722-514-30 | Camber PharmaceuticalsIndia | 9 December 2014 |
| 90 tablet, film coated in 1 bottle | 31722-514-90 | Camber PharmaceuticalsIndia | 9 December 2014 |
| 1000 tablet, film coated in 1 bottle | 68180-465-03 | LupinIndia | 9 March 2016 |
| 30 tablet, film coated in 1 bottle | 68180-465-06 | LupinIndia | 5 January 2016 |
| 90 tablet, film coated in 1 bottle | 68180-465-09 | LupinIndia | 19 February 2016 |
| 100 tablet, film coated in 1 bottle | 72865-309-01 | XLCare Pharmaceuticals | 21 January 2026 |
| 500 tablet, film coated in 1 bottle | 72865-309-05 | XLCare Pharmaceuticals | 21 January 2026 |
| 1000 tablet, film coated in 1 bottle | 72865-309-10 | XLCare Pharmaceuticals | 21 January 2026 |
| 30 tablet, film coated in 1 bottle | 72865-309-30 | XLCare Pharmaceuticals | 21 January 2026 |
| 45 tablet, film coated in 1 bottle | 72865-309-45 | XLCare Pharmaceuticals | 21 January 2026 |
| 90 tablet, film coated in 1 bottle | 72865-309-90 | XLCare Pharmaceuticals | 21 January 2026 |
| 30 tablet, film coated in 1 bottle | 50090-5788-0 | A-S Medication Solutions | 8 October 2021 |
| 90 tablet, film coated in 1 bottle | 50090-5788-1 | A-S Medication Solutions | 8 October 2021 |
| 30 tablet, film coated in 1 bottle | 50090-7088-0 | A-S Medication Solutions | 12 February 2024 |
| 90 tablet, film coated in 1 bottle | 50090-7088-1 | A-S Medication Solutions | 9 February 2024 |
| 45 tablet, film coated in 1 bottle | 50090-7783-0 | A-S Medication Solutions | 20 November 2025 |
| 90 tablet, film coated in 1 bottle | 50090-7783-1 | A-S Medication Solutions | 20 November 2025 |
| 1000 tablet, film coated in 1 bottle | 50090-7783-2 | A-S Medication Solutions | 20 November 2025 |
| 45 tablet, film coated in 1 bottle | 53401-018-45 | Aphena Pharma Solutions - Tennessee | 2 July 2026 |
| 45 tablet, film coated in 1 bottle | 71610-611-45 | Aphena Pharma Solutions - Tennessee | 25 October 2021 |
| 30 tablet, film coated in 1 bottle | 63629-3408-1 | Bryant Ranch Prepack | 8 August 2024 |
| 60 tablet, film coated in 1 bottle | 63629-3408-2 | Bryant Ranch Prepack | 8 August 2024 |
| 90 tablet, film coated in 1 bottle | 63629-3408-3 | Bryant Ranch Prepack | 27 September 2010 |
| 100 tablet, film coated in 1 bottle | 63629-3408-4 | Bryant Ranch Prepack | 18 February 2009 |
| 10 tablet, film coated in 1 bottle | 63629-3408-5 | Bryant Ranch Prepack | 8 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 23 December 1991 | 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
Other strengths and forms of Simvastatin
Clinical summary
Simvastatin is an HMG-CoA reductase inhibitor indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, among other approved uses. It is available as tablets for oral use. MedsAcross supplies 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 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
- ZOCOR prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Simvastatin 80 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.