Medicine
Nisoldipine 8.5 mg extended-release tablet
Nisoldipine 8.5 mg extended-release tablet is a generic prescription medicine for oral use, made by 2 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°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F).
Key facts
- Active ingredient (INN)
- Nisoldipine
- Brand
- Sold under the generic name
- Strength
- 8.5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 1 bottle
- Manufacturers
- Avet PharmaceuticalsIndiaPrasco Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C08CA07 Nisoldipine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 February 2012
- Identifiers
- RxCUI 763519, 763589, 790489DailyMed set ID 8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb, a52b773a-44f9-442f-a4be-39f79a558bd2NDC 66993-472, 23155-976Application NDA020356, ANDA216606
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 100 tablet, film coated, extended release in 1 bottle | 23155-976-01 | Avet PharmaceuticalsIndia | 1 August 2026 |
| 1 bottle in 1 carton / 100 tablet, film coated, extended release in 1 bottle | 66993-472-02 | Prasco Laboratories | 27 February 2012 |
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 2 February 1995 | 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 Nisoldipine 8.5 mg extended-release tablet.
Other strengths and forms of Nisoldipine
Clinical summary
Nisoldipine is a dihydropyridine calcium channel blocker indicated for the treatment of hypertension. It is available as extended-release tablets for oral use. MedsAcross supplies Nisoldipine 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 NisoldipineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sular prescribing information (Covis Pharma) · U.S. National Library of Medicine, DailyMed
Need Nisoldipine 8.5 mg extended-release 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.