Medicine
Rosuvastatin 40 mg tablet
Rosuvastatin 40 mg tablet is a generic prescription medicine for oral use, made by 35 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 controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF), excursions…
Key facts
- Active ingredient (INN)
- Rosuvastatin
- Brand
- Sold under the generic name
- Strength
- 40 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 30 tablets, 90 tablets and 160 more
- Manufacturers
- Glenmark PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaAurobindo PharmaIndiaAscend LaboratoriesIndiaBioconIndiaCamber PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaAccord HealthcareIndiaLifestar PharmaIndiaCadila PharmaceuticalsIndia35 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AA07 Rosuvastatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 July 2016
- Identifiers
- RxCUI 859419, 859424, 859747 +1DailyMed set ID 1185b112-f59d-8762-e063-6394a90a120d, dc7bfc79-9ee3-46e7-b55d-aba88648ad3b, 989dffcf-0254-439d-9f3f-3b0e9d32de0a +37NDC 71610-798, 82804-176, 60290-046 +37Application ANDA206381, ANDA208898, ANDA207626 +17
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 35 labelers. The register lists 163 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet, coated in 1 bottle | 13668-182-05 | Torrent PharmaceuticalsIndia | 31 October 2016 |
| 30 tablet, coated in 1 bottle | 13668-182-30 | Torrent PharmaceuticalsIndia | 31 October 2016 |
| 90 tablet, coated in 1 bottle | 13668-182-90 | Torrent PharmaceuticalsIndia | 31 October 2016 |
| 500 tablet in 1 bottle | 13668-723-05 | Torrent PharmaceuticalsIndia | 1 August 2023 |
| 1000 tablet in 1 bottle | 13668-723-10 | Torrent PharmaceuticalsIndia | 20 December 2024 |
| 30 tablet in 1 bottle | 13668-723-30 | Torrent PharmaceuticalsIndia | 1 August 2023 |
| 30 tablet, film coated in 1 bottle | 16729-287-10 | Accord HealthcareIndia | 31 October 2016 |
| 90 tablet, film coated in 1 bottle | 16729-287-15 | Accord HealthcareIndia | 31 October 2016 |
| 1000 tablet, film coated in 1 bottle | 16729-287-17 | Accord HealthcareIndia | 31 October 2016 |
| 500 tablet, film coated in 1 bottle | 67877-442-05 | Ascend LaboratoriesIndia | 21 March 2017 |
| 30 tablet, film coated in 1 bottle | 67877-442-30 | Ascend LaboratoriesIndia | 21 March 2017 |
| 10 tablet, film coated in 1 carton | 67877-442-38 | Ascend LaboratoriesIndia | 21 March 2017 |
| 90 tablet, film coated in 1 bottle | 67877-442-90 | Ascend LaboratoriesIndia | 21 March 2017 |
| 500 tablet, film coated in 1 bottle | 65862-296-05 | Aurobindo PharmaIndia | 19 July 2016 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-296-10 | Aurobindo PharmaIndia | 19 July 2016 |
| 30 tablet, film coated in 1 bottle | 65862-296-30 | Aurobindo PharmaIndia | 19 July 2016 |
| 90 tablet, film coated in 1 bottle | 65862-296-90 | Aurobindo PharmaIndia | 19 July 2016 |
| 1000 tablet, film coated in 1 bottle | 65862-296-99 | Aurobindo PharmaIndia | 19 July 2016 |
| 30 tablet, film coated in 1 bottle, plastic | 70377-009-11 | BioconIndia | 31 October 2016 |
| 90 tablet, film coated in 1 bottle, plastic | 70377-009-12 | BioconIndia | 31 October 2016 |
| 500 tablet, film coated in 1 bottle, plastic | 70377-009-13 | BioconIndia | 31 October 2016 |
| 1000 tablet, film coated in 1 bottle, plastic | 70377-009-15 | BioconIndia | 27 September 2019 |
| 30 tablet, film coated in 1 bottle | 71209-046-01 | Cadila PharmaceuticalsIndia | 21 November 2018 |
| 500 tablet, film coated in 1 bottle | 31722-885-05 | Camber PharmaceuticalsIndia | 4 January 2021 |
| 1000 tablet, film coated in 1 bottle | 31722-885-10 | Camber PharmaceuticalsIndia | 4 January 2021 |
| 30 tablet, film coated in 1 bottle | 31722-885-30 | Camber PharmaceuticalsIndia | 29 October 2016 |
| 100 tablet, film coated in 1 carton | 31722-885-31 | Camber PharmaceuticalsIndia | 29 October 2016 |
| 100 tablet, film coated in 1 bottle | 68462-264-01 | Glenmark PharmaceuticalsIndia | 19 July 2016 |
| 500 tablet, film coated in 1 bottle | 68462-264-05 | Glenmark PharmaceuticalsIndia | 4 March 2021 |
| 1000 tablet, film coated in 1 bottle | 68462-264-10 | Glenmark PharmaceuticalsIndia | 19 July 2016 |
| 30 tablet, film coated in 1 bottle | 68462-264-30 | Glenmark PharmaceuticalsIndia | 19 July 2016 |
| 50 tablet, film coated in 1 bottle | 68462-264-50 | Glenmark PharmaceuticalsIndia | 19 July 2016 |
| 90 tablet, film coated in 1 bottle | 68462-264-90 | Glenmark PharmaceuticalsIndia | 19 July 2016 |
| 1000 tablet, film coated in 1 bottle | 70756-056-12 | Lifestar PharmaIndia | 16 August 2026 |
| 30 tablet, film coated in 1 bottle | 70756-056-30 | Lifestar PharmaIndia | 16 August 2026 |
| 90 tablet, film coated in 1 bottle | 70756-056-90 | Lifestar PharmaIndia | 16 August 2026 |
| 30 tablet in 1 container | 33342-264-07 | Macleods PharmaceuticalsIndia | 6 November 2024 |
| 90 tablet in 1 container | 33342-264-10 | Macleods PharmaceuticalsIndia | 6 November 2024 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-264-12 | Macleods PharmaceuticalsIndia | 6 November 2024 |
| 1000 tablet in 1 container | 33342-264-44 | Macleods PharmaceuticalsIndia | 6 November 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 12 August 2003 | 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 Rosuvastatin 40 mg tablet.
Other strengths and forms of Rosuvastatin
Clinical summary
Rosuvastatin is an HMG-CoA reductase inhibitor indicated to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for these events. MedsAcross supplies Rosuvastatin 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 RosuvastatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Crestor prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Rosuvastatin 40 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.