Medicine
Amlodipine 5 mg tablet
Amlodipine 5 mg tablet is a generic prescription medicine for oral use, made by 36 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 to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Amlodipine
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 500 tablets, 1000 tablets, 10 blister pack and 185 more
- Manufacturers
- Zydus LifesciencesIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaCiplaIndiaUnichem LaboratoriesIndiaLupinIndiaExelan PharmaceuticalsChina Resources Saike PharmaceuticalEpic Pharma36 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F), and dispense in tight, light resistant container (USP).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C08CA01 Amlodipine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 May 2007
- Identifiers
- RxCUI 197361, 308135, 308136DailyMed set ID 1b449c22-0181-4a50-94b3-26139b90b978, 186b6149-9610-4380-9bf2-941646069276, 49104797-8202-1376-e063-6294a90adb38 +37NDC 71335-1278, 71610-691, 71610-985 +37Application ANDA078925, ANDA078552, ANDA078414 +12
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 36 labelers. The register lists 188 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 tablet in 1 bottle | 67877-198-05 | Ascend LaboratoriesIndia | 20 October 2010 |
| 1000 tablet in 1 bottle | 67877-198-10 | Ascend LaboratoriesIndia | 20 October 2010 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 67877-198-38 | Ascend LaboratoriesIndia | 20 October 2010 |
| 90 tablet in 1 bottle | 67877-198-90 | Ascend LaboratoriesIndia | 20 October 2010 |
| 500 tablet in 1 bottle | 67877-901-05 | Ascend LaboratoriesIndia | 21 May 2026 |
| 1000 tablet in 1 bottle | 67877-901-10 | Ascend LaboratoriesIndia | 1 April 2026 |
| 90 tablet in 1 bottle | 67877-901-90 | Ascend LaboratoriesIndia | 1 February 2026 |
| 90 tablet in 1 bottle | 69097-127-05 | CiplaIndia | 26 September 2007 |
| 1000 tablet in 1 bottle | 69097-127-15 | CiplaIndia | 26 September 2007 |
| 90 tablet in 1 bottle | 69097-837-05 | CiplaIndia | 1 July 2016 |
| 1000 tablet in 1 bottle | 69097-837-15 | CiplaIndia | 1 July 2016 |
| 100 tablet in 1 bottle | 65841-621-01 | Zydus LifesciencesIndia | 21 September 2007 |
| 500 tablet in 1 bottle | 65841-621-05 | Zydus LifesciencesIndia | 21 September 2007 |
| 90 tablet in 1 bottle | 65841-621-16 | Zydus LifesciencesIndia | 21 September 2007 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 65841-621-77 | Zydus LifesciencesIndia | 21 September 2007 |
| 100 tablet in 1 bottle | 68382-122-01 | Zydus LifesciencesIndia | 21 September 2007 |
| 500 tablet in 1 bottle | 68382-122-05 | Zydus LifesciencesIndia | 21 September 2007 |
| 90 tablet in 1 bottle | 68382-122-16 | Zydus LifesciencesIndia | 21 September 2007 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 68382-122-77 | Zydus LifesciencesIndia | 21 September 2007 |
| 500 tablet in 1 bottle | 65862-102-05 | Aurobindo PharmaIndia | 17 July 2007 |
| 30 tablet in 1 bottle | 65862-102-30 | Aurobindo PharmaIndia | 17 July 2007 |
| 90 tablet in 1 bottle | 65862-102-90 | Aurobindo PharmaIndia | 17 July 2007 |
| 1000 tablet in 1 bottle | 65862-102-99 | Aurobindo PharmaIndia | 17 July 2007 |
| 90 tablet in 1 bottle | 68180-455-01 | LupinIndia | 24 June 2024 |
| 1000 tablet in 1 bottle | 68180-455-02 | LupinIndia | 12 June 2024 |
| 500 tablet in 1 bottle, plastic | 29300-397-05 | Unichem LaboratoriesIndia | 22 June 2020 |
| 1000 tablet in 1 bottle, plastic | 29300-397-10 | Unichem LaboratoriesIndia | 22 June 2020 |
| 90 tablet in 1 bottle, plastic | 29300-397-19 | Unichem LaboratoriesIndia | 22 June 2020 |
| 500 tablet in 1 bottle | 76282-238-05 | Exelan Pharmaceuticals | 2 November 2007 |
| 1000 tablet in 1 bottle | 76282-238-10 | Exelan Pharmaceuticals | 2 November 2007 |
| 90 tablet in 1 bottle | 76282-238-90 | Exelan Pharmaceuticals | 2 November 2007 |
| 500 tablet in 1 bottle | 76282-508-05 | Exelan Pharmaceuticals | 15 March 2022 |
| 1000 tablet in 1 bottle | 76282-508-10 | Exelan Pharmaceuticals | 15 March 2022 |
| 90 tablet in 1 bottle | 76282-508-90 | Exelan Pharmaceuticals | 15 March 2022 |
| 90 tablet in 1 bottle, plastic | 43489-100-01 | China Resources Saike Pharmaceutical | 23 May 2016 |
| 500 tablet in 1 bottle, plastic | 43489-100-03 | China Resources Saike Pharmaceutical | 23 May 2016 |
| 1000 tablet in 1 bottle, plastic | 43489-100-05 | China Resources Saike Pharmaceutical | 23 May 2016 |
| 500 tablet in 1 bottle | 42806-056-05 | Epic Pharma | 25 April 2011 |
| 90 tablet in 1 bottle | 42806-056-09 | Epic Pharma | 25 April 2011 |
| 1000 tablet in 1 bottle | 42806-056-10 | Epic Pharma | 25 April 2011 |
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 31 July 1992 | 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 Amlodipine 5 mg tablet.
Other strengths and forms of Amlodipine
Clinical summary
Amlodipine is a dihydropyridine calcium channel blocker indicated for the treatment of hypertension, to lower blood pressure, among other approved uses. It is available as tablets, oral solution and oral suspension. MedsAcross supplies Amlodipine 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 AmlodipineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- amlodipine besylate prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Amlodipine 5 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.