Medicine
Pitavastatin 1 mg tablet
Pitavastatin 1 mg tablet is a generic prescription medicine for oral use, made by 7 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), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Pitavastatin
- Brand
- Sold under the generic name
- Strength
- 1 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 90 tablets, 500 tablets, 30 tablets and 8 more
- Manufacturers
- Aurobindo PharmaIndiaZydus LifesciencesIndiaAmneal PharmaceuticalsGolden State Medical SupplyMylan PharmaceuticalsUpsher-Smith LaboratoriesXLCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10AA08 Pitavastatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 February 2017
- Identifiers
- RxCUI 861643, 861648, 861652DailyMed set ID 7fbfcc0c-9251-456d-a525-e62cfd8abd4b, 26b5e5e8-45cd-4a98-9af4-2d04c1130881, 9ad1ecb9-822d-47c1-9f6f-6f771fa0f924 +5NDC 65162-029, 0378-5055, 0832-6048 +5Application ANDA205961, ANDA206070, ANDA205955 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 90 tablet in 1 bottle | 68382-481-16 | Zydus LifesciencesIndia | 2 November 2023 |
| 90 tablet in 1 bottle | 70771-1784-9 | Zydus LifesciencesIndia | 2 November 2023 |
| 500 tablet, film coated in 1 bottle | 65862-812-05 | Aurobindo PharmaIndia | 2 November 2023 |
| 90 tablet, film coated in 1 bottle | 65862-812-90 | Aurobindo PharmaIndia | 2 November 2023 |
| 30 tablet, film coated in 1 bottle | 65162-029-03 | Amneal Pharmaceuticals | 21 August 2024 |
| 90 tablet, film coated in 1 bottle | 65162-029-09 | Amneal Pharmaceuticals | 21 August 2024 |
| 500 tablet, film coated in 1 bottle | 65162-029-50 | Amneal Pharmaceuticals | 21 August 2024 |
| 90 tablet, film coated in 1 bottle, plastic | 0378-5055-77 | Mylan Pharmaceuticals | 2 November 2023 |
| 90 tablet in 1 bottle | 0832-6048-90 | Upsher-Smith Laboratories | 2 November 2023 |
| 90 tablet, film coated in 1 bottle | 72865-291-90 | XLCare Pharmaceuticals | 18 September 2025 |
| 90 tablet in 1 bottle | 51407-956-90 | Golden State Medical Supply | 26 December 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 3 August 2009 | 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 Pitavastatin
Clinical summary
Pitavastatin is an HMG-CoA reductase inhibitor indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. It is available as tablets for oral use. MedsAcross supplies Pitavastatin 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 PitavastatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Livalo prescribing information (Kowa Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Pitavastatin 1 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.