Medicine
Simvastatin 5 mg tablet
Simvastatin 5 mg tablet is a generic prescription medicine for oral use, made by 12 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
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 1000 tablets and 38 more
- Manufacturers
- Aurobindo PharmaIndiaBioconIndiaCamber PharmaceuticalsIndiaAccord HealthcareIndiaBryant Ranch PrepackA-S Medication SolutionsXLCare PharmaceuticalsGolden State Medical SupplyNorthStar RxQuallent Pharmaceuticals Health12 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 433f8a86-5ad3-43db-8e62-c0812dd3d723, 4cc35f5f-2d3e-dedd-e063-6294a90a5cbe, 4312637b-1d6a-4d26-a1e8-caffcd7192df +12NDC 72865-305, 84677-014, 50090-7777 +12Application ANDA200895, ANDA078034, ANDA077691 +2
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 12 labelers. The register lists 41 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 | 16729-156-10 | Accord HealthcareIndia | 7 November 2014 |
| 90 tablet, film coated in 1 bottle | 16729-156-15 | Accord HealthcareIndia | 12 September 2014 |
| 1000 tablet, film coated in 1 bottle | 16729-156-17 | Accord HealthcareIndia | 22 April 2015 |
| 100 tablet, film coated in 1 bottle | 65862-050-00 | Aurobindo PharmaIndia | 20 December 2006 |
| 100 tablet, film coated in 1 bottle | 65862-050-01 | Aurobindo PharmaIndia | 20 December 2006 |
| 2500 tablet, film coated in 1 bottle | 65862-050-26 | Aurobindo PharmaIndia | 20 December 2006 |
| 30 tablet, film coated in 1 bottle | 65862-050-30 | Aurobindo PharmaIndia | 20 December 2006 |
| 45 tablet, film coated in 1 bottle | 65862-050-45 | Aurobindo PharmaIndia | 20 December 2006 |
| 90 tablet, film coated in 1 bottle | 65862-050-90 | Aurobindo PharmaIndia | 20 December 2006 |
| 1000 tablet, film coated in 1 bottle | 65862-050-99 | Aurobindo PharmaIndia | 20 December 2006 |
| 30 tablet, film coated in 1 bottle | 70377-001-12 | BioconIndia | 17 December 2015 |
| 45 tablet, film coated in 1 bottle | 70377-001-13 | BioconIndia | 17 December 2015 |
| 90 tablet, film coated in 1 bottle | 70377-001-14 | BioconIndia | 17 December 2015 |
| 1000 tablet, film coated in 1 bottle | 70377-001-15 | BioconIndia | 17 December 2015 |
| 100 tablet, film coated in 1 bottle | 31722-510-01 | Camber PharmaceuticalsIndia | 9 December 2014 |
| 1000 tablet, film coated in 1 bottle | 31722-510-10 | Camber PharmaceuticalsIndia | 9 December 2014 |
| 30 tablet, film coated in 1 bottle | 31722-510-30 | Camber PharmaceuticalsIndia | 9 December 2014 |
| 90 tablet, film coated in 1 bottle | 31722-510-90 | Camber PharmaceuticalsIndia | 9 December 2014 |
| 100 tablet, film coated in 1 bottle | 72865-305-01 | XLCare Pharmaceuticals | 21 January 2026 |
| 1000 tablet, film coated in 1 bottle | 72865-305-10 | XLCare Pharmaceuticals | 21 January 2026 |
| 30 tablet, film coated in 1 bottle | 72865-305-30 | XLCare Pharmaceuticals | 21 January 2026 |
| 90 tablet, film coated in 1 bottle | 72865-305-90 | XLCare Pharmaceuticals | 21 January 2026 |
| 30 tablet, film coated in 1 bottle | 50090-6459-0 | A-S Medication Solutions | 1 May 2023 |
| 30 tablet, film coated in 1 bottle | 50090-7776-0 | A-S Medication Solutions | 20 November 2025 |
| 90 tablet, film coated in 1 bottle | 50090-7777-0 | A-S Medication Solutions | 20 November 2025 |
| 1000 tablet, film coated in 1 bottle | 50090-7777-1 | A-S Medication Solutions | 20 November 2025 |
| 30 tablet, film coated in 1 bottle | 63629-7421-1 | Bryant Ranch Prepack | 4 April 2018 |
| 90 tablet, film coated in 1 bottle | 63629-7421-2 | Bryant Ranch Prepack | 23 October 2017 |
| 60 tablet, film coated in 1 bottle | 63629-7421-3 | Bryant Ranch Prepack | 8 August 2024 |
| 10 tablet, film coated in 1 bottle | 63629-7421-4 | Bryant Ranch Prepack | 8 August 2024 |
| 30 tablet, film coated in 1 bottle | 71335-2262-1 | Bryant Ranch Prepack | 3 April 2024 |
| 90 tablet, film coated in 1 bottle | 71335-2262-2 | Bryant Ranch Prepack | 10 October 2023 |
| 60 tablet, film coated in 1 bottle | 71335-2262-3 | Bryant Ranch Prepack | 3 April 2024 |
| 10 tablet, film coated in 1 bottle | 71335-2262-4 | Bryant Ranch Prepack | 3 April 2024 |
| 1000 tablet, film coated in 1 bottle | 84677-014-10 | Golden State Medical Supply | 10 March 2026 |
| 90 tablet, film coated in 1 bottle | 84677-014-90 | Golden State Medical Supply | 10 March 2026 |
| 30 tablet, film coated in 1 bottle | 16714-681-01 | NorthStar Rx | 20 December 2006 |
| 90 tablet, film coated in 1 bottle | 16714-681-02 | NorthStar Rx | 20 December 2006 |
| 1000 tablet, film coated in 1 bottle | 82009-012-10 | Quallent Pharmaceuticals Health | 26 May 2022 |
| 30 tablet, film coated in 1 blister pack | 70518-4102-0 | Remedyrepack | 14 June 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 5 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.