Medicine
Pitavastatin 1.045 mg tablet
Pitavastatin 1.045 mg tablet is a generic prescription medicine for oral use, made by 3 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 from 15°C-30°C (59°F-86°F)…
Key facts
- Active ingredient (INN)
- Pitavastatin
- Brand
- Sold under the generic name
- Strength
- 1.045 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 90 tablets
- Manufacturers
- Camber PharmaceuticalsIndiaAvKARETeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77° F), excursions permitted from 15°C-30°C (59°F-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
- 2 November 2023
- Identifiers
- RxCUI 861643, 861648, 861652DailyMed set ID 0f11ee80-871e-4f13-e063-6394a90af19d, e9622824-cee5-49d7-9273-f18b9cc176fd, fac09182-dcf2-1770-e053-6394a90af50cNDC 42291-905, 31722-875, 0480-3631Application ANDA205932, ANDA205977
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, film coated in 1 bottle | 31722-875-90 | Camber PharmaceuticalsIndia | 30 April 2024 |
| 90 tablet, film coated in 1 bottle | 0480-3631-98 | Teva Pharmaceuticals | 2 November 2023 |
| 90 tablet, film coated in 1 bottle | 42291-905-90 | AvKARE | 16 January 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
Alternatives
Other makers and brands of Pitavastatin 1.045 mg tablet.
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 1.045 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.