Medicine
Pravastatin 80 mg tablet
Pravastatin 80 mg tablet is a generic prescription medicine for oral use, made by 22 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 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)…
Key facts
- Active ingredient (INN)
- Pravastatin
- Brand
- Sold under the generic name
- Strength
- 80 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 90 tablets, 1000 tablets and 68 more
- Manufacturers
- Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaBioconIndiaAccord HealthcareIndiaCiplaIndiaGlenmark PharmaceuticalsIndiaBryant Ranch PrepackApotexAmici PharmaTeva Pharmaceuticals22 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Keep tightly closed (protect from moisture). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AA03 Pravastatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 December 2007
- Identifiers
- RxCUI 904458, 904467, 904475 +1DailyMed set ID 25b7276e-a69f-af63-e063-6394a90aecf2, f87016fb-4c01-4279-8cf7-59819971ca15, ebd794ba-90c3-4d81-9c45-4aa9d9454359 +29NDC 51407-890, 62135-850, 68788-7660 +29Application ANDA209869, ANDA077917, ANDA076341 +6
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 22 labelers. The register lists 71 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet in 1 bottle | 65862-635-05 | Aurobindo PharmaIndia | 2 February 2017 |
| 90 tablet in 1 bottle | 65862-635-90 | Aurobindo PharmaIndia | 2 February 2017 |
| 90 tablet in 1 bottle | 84386-034-90 | Aurobindo PharmaIndia | 27 February 2025 |
| 1000 tablet in 1 bottle | 84386-034-99 | Aurobindo PharmaIndia | 27 February 2025 |
| 90 tablet in 1 bottle | 84386-167-90 | Aurobindo PharmaIndia | 4 September 2026 |
| 1000 tablet in 1 bottle | 84386-167-99 | Aurobindo PharmaIndia | 4 September 2026 |
| 90 tablet in 1 bottle | 16729-011-15 | Accord HealthcareIndia | 16 February 2017 |
| 500 tablet in 1 bottle | 16729-011-16 | Accord HealthcareIndia | 16 February 2017 |
| 30 tablet in 1 bottle | 70377-048-11 | BioconIndia | 1 February 2021 |
| 90 tablet in 1 bottle | 70377-048-12 | BioconIndia | 1 February 2021 |
| 500 tablet in 1 bottle | 70377-048-13 | BioconIndia | 1 February 2021 |
| 90 tablet in 1 bottle | 69097-792-05 | CiplaIndia | 1 June 2024 |
| 500 tablet in 1 bottle | 69097-792-12 | CiplaIndia | 1 June 2024 |
| 100 tablet in 1 bottle | 55111-274-01 | Dr. Reddy's LaboratoriesIndia | 31 December 2009 |
| 500 tablet in 1 bottle | 55111-274-05 | Dr. Reddy's LaboratoriesIndia | 31 December 2009 |
| 30 tablet in 1 bottle | 55111-274-30 | Dr. Reddy's LaboratoriesIndia | 31 December 2009 |
| 90 tablet in 1 bottle | 55111-274-90 | Dr. Reddy's LaboratoriesIndia | 31 December 2009 |
| 500 tablet in 1 bottle | 68462-198-05 | Glenmark PharmaceuticalsIndia | 28 December 2007 |
| 90 tablet in 1 bottle | 68462-198-90 | Glenmark PharmaceuticalsIndia | 28 December 2007 |
| 1000 tablet in 1 bottle | 69292-104-10 | Amici Pharma | 19 May 2026 |
| 500 tablet in 1 bottle | 69292-104-50 | Amici Pharma | 19 May 2026 |
| 90 tablet in 1 bottle | 69292-104-90 | Amici Pharma | 19 May 2026 |
| 100 tablet in 1 bottle | 60505-1323-1 | Apotex | 18 July 2011 |
| 500 tablet in 1 bottle | 60505-1323-5 | Apotex | 18 July 2011 |
| 1000 tablet in 1 bottle | 60505-1323-7 | Apotex | 18 July 2011 |
| 5000 tablet in 1 bottle | 60505-1323-8 | Apotex | 18 July 2011 |
| 90 tablet in 1 bottle | 60505-1323-9 | Apotex | 18 July 2011 |
| 90 tablet, film coated in 1 bottle | 62135-850-90 | Chartwell RX | 26 September 2024 |
| 1000 tablet in 1 bottle | 0480-7270-10 | Teva Pharmaceuticals | 20 March 2023 |
| 90 tablet in 1 bottle | 0480-7270-98 | Teva Pharmaceuticals | 9 February 2023 |
| 30 tablet in 1 bottle | 63629-7508-1 | Bryant Ranch Prepack | 8 January 2019 |
| 90 tablet in 1 bottle | 63629-7508-2 | Bryant Ranch Prepack | 19 January 2018 |
| 58 tablet in 1 bottle | 63629-7508-3 | Bryant Ranch Prepack | 19 March 2021 |
| 88 tablet in 1 bottle | 63629-7508-4 | Bryant Ranch Prepack | 26 March 2021 |
| 10 tablet in 1 bottle | 63629-7508-5 | Bryant Ranch Prepack | 24 January 2025 |
| 90 tablet in 1 bottle | 63629-8836-1 | Bryant Ranch Prepack | 18 July 2011 |
| 90 tablet in 1 bottle | 63629-8912-1 | Bryant Ranch Prepack | 19 November 2021 |
| 500 tablet in 1 bottle | 63629-8913-1 | Bryant Ranch Prepack | 19 November 2021 |
| 30 tablet in 1 bottle | 63629-9165-1 | Bryant Ranch Prepack | 4 February 2022 |
| 60 tablet in 1 bottle | 63629-9165-2 | Bryant Ranch Prepack | 4 February 2022 |
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 October 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 Pravastatin
Clinical summary
Pravastatin is an HMG-CoA reductase inhibitor indicated to reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). MedsAcross supplies Pravastatin 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 PravastatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Pravastatin Sodium prescribing information (NorthStar RxLLC) · U.S. National Library of Medicine, DailyMed
Need Pravastatin 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.