Medicine
Amlodipine and Atorvastatin 5 mg/20 mg tablet
Amlodipine and Atorvastatin 5 mg/20 mg tablet is a generic prescription medicine for oral use, made by 6 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 to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Amlodipine and Atorvastatin
- Brand
- Sold under the generic name
- Strength
- 5 mg/20 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 90 tablets, 500 tablets and 9 more
- Manufacturers
- Alembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaApotexBryant Ranch PrepackMylan PharmaceuticalsPrasco Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C10BX03 Amlodipine and Atorvastatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 March 2014
- Identifiers
- RxCUI 404011, 404013, 597967 +7DailyMed set ID 1346631f-e6db-4c5c-a6af-5aa7b80a011d, 50112e22-5a69-47c9-90cd-82bbacae7418, 4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03 +4NDC 62332-759, 72162-2093, 60505-3483 +4Application ANDA217279, ANDA205199, NDA021540 +2
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 |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 46708-759-30 | Alembic PharmaceuticalsIndia | 23 May 2025 |
| 90 tablet, film coated in 1 bottle | 46708-759-90 | Alembic PharmaceuticalsIndia | 23 May 2025 |
| 30 tablet, film coated in 1 bottle | 62332-759-30 | Alembic PharmaceuticalsIndia | 23 May 2025 |
| 90 tablet, film coated in 1 bottle | 62332-759-90 | Alembic PharmaceuticalsIndia | 23 May 2025 |
| 500 tablet, film coated in 1 bottle | 43598-319-05 | Dr. Reddy's LaboratoriesIndia | 17 March 2014 |
| 30 tablet, film coated in 1 bottle | 43598-319-30 | Dr. Reddy's LaboratoriesIndia | 17 March 2014 |
| 60 tablet, film coated in 1 bottle | 43598-319-60 | Dr. Reddy's LaboratoriesIndia | 17 March 2014 |
| 90 tablet, film coated in 1 bottle | 43598-319-90 | Dr. Reddy's LaboratoriesIndia | 17 March 2014 |
| 30 tablet, film coated in 1 bottle | 60505-3483-3 | Apotex | 29 July 2020 |
| 30 tablet, film coated in 1 bottle, plastic | 0378-4514-93 | Mylan Pharmaceuticals | 21 May 2014 |
| 30 tablet, film coated in 1 bottle | 72162-2093-3 | Bryant Ranch Prepack | 20 March 2026 |
| 30 tablet, coated in 1 bottle | 66993-267-30 | Prasco Laboratories | 14 March 2022 |
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 30 January 2004 | 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 and Atorvastatin 5 mg/20 mg tablet.
Other strengths and forms of Amlodipine and Atorvastatin
Clinical summary
Amlodipine and Atorvastatin is a fixed-dose combination of a dihydropyridine calcium channel blocker, an HMG-CoA reductase inhibitor and a calcium channel blocker indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. MedsAcross supplies Amlodipine and Atorvastatin 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 Amlodipine and AtorvastatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Caduet prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Amlodipine and Atorvastatin 5 mg/20 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.