Medicine
Isradipine 5 mg capsule
Isradipine 5 mg capsule 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 and Dispense Store at 20° to 25°C (68° to 77°F) and dispense in a tight…
Key facts
- Active ingredient (INN)
- Isradipine
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 500 capsules
- Manufacturers
- Elite LaboratoriesTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store and Dispense Store at 20° to 25°C (68° to 77°F) and dispense in a tight, light-resistant container.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C08CA03 Isradipine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 January 2006
- Identifiers
- RxCUI 197848, 197849DailyMed set ID bf3425e0-428d-4bdb-ac9a-3b9d483df83a, acf7c376-6cb6-4857-b455-0bf5da29346cNDC 16252-540, 64850-911Application ANDA077317, ANDA077169
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 |
|---|---|---|---|
| 100 capsule in 1 bottle | 64850-911-01 | Elite Laboratories | 28 December 2022 |
| 500 capsule in 1 bottle | 64850-911-05 | Elite Laboratories | 28 December 2022 |
| 100 capsule in 1 bottle | 16252-540-01 | Teva Pharmaceuticals | 5 January 2006 |
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 20 December 1990 | 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 Isradipine
Clinical summary
Isradipine is a dihydropyridine calcium channel blocker indicated in the management of hypertension. It is available as capsules for oral use. MedsAcross supplies Isradipine 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 IsradipineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Isradipine prescribing information (Teva Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Isradipine 5 mg capsule 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.