Medicine
Norvasc 5 mg tablet
Norvasc 5 mg tablet is a prescription medicine containing Amlodipine for oral use, marketed by Viatris Specialty, 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 bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and…
Key facts
- Active ingredient (INN)
- Amlodipine
- Brand
- Norvasc
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 300 tablets, 90 tablets, 100 blister pack and 1 more
- Marketing authorisation holder
- Viatris Specialty
- Manufacturers
- Viatris SpecialtyPfizer Laboratories
- Origin register
- US FDA, United States
- Storage
- Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (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
- 31 July 1992
- Identifiers
- RxCUI 197361, 212542, 212549 +3DailyMed set ID 7367289c-b0b0-466a-83e2-558e2985c29f, abd6a2ca-40c2-485c-bc53-db1c652505edNDC 58151-354, 0069-1530Application NDA019787
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 300 tablet in 1 bottle | 58151-354-30 | Viatris Specialty | 23 January 2025 |
| 90 tablet in 1 bottle | 58151-354-77 | Viatris Specialty | 31 December 2024 |
| 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 58151-354-88 | Viatris Specialty | 24 September 2024 |
| 90 tablet in 1 bottle | 0069-1530-68 | Pfizer Laboratories | 31 July 1992 |
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 Norvasc 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.