Medicine
Carvedilol 12.5 mg tablet
Carvedilol 12.5 mg tablet is a generic prescription medicine for oral use, made by 26 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). Protect from moisture.
Key facts
- Active ingredient (INN)
- Carvedilol
- Brand
- Sold under the generic name
- Strength
- 12.5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 28 tablets and 105 more
- Manufacturers
- Zydus LifesciencesIndiaDr. Reddy's LaboratoriesIndiaGlenmark PharmaceuticalsIndiaAurobindo PharmaIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackAdvagen PharmaMethod PharmaceuticalsTeva Pharmaceuticals26 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20 to 25°C (68 to 77°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C07AG02 Carvedilol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 September 2007
- Identifiers
- RxCUI 200031, 200032, 200033 +1DailyMed set ID 7cc14b86-0833-4c3c-91f3-7963d7052fd5, b4e700f8-d0e0-4ad5-93b5-e935389a96e3, 205291ba-86a7-43e1-be47-bc75df1921f9 +34NDC 65862-144, 71335-1533, 72888-501 +34Application ANDA078332, ANDA078251, ANDA078786 +6
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 26 labelers. The register lists 108 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65841-618-01 | Zydus LifesciencesIndia | 5 September 2007 |
| 500 tablet, film coated in 1 bottle | 65841-618-05 | Zydus LifesciencesIndia | 5 September 2007 |
| 28 tablet, film coated in 1 bottle | 65841-618-17 | Zydus LifesciencesIndia | 5 September 2007 |
| 100 tablet, film coated in 1 bottle | 68382-094-01 | Zydus LifesciencesIndia | 5 September 2007 |
| 500 tablet, film coated in 1 bottle | 68382-094-05 | Zydus LifesciencesIndia | 5 September 2007 |
| 28 tablet, film coated in 1 bottle | 68382-094-17 | Zydus LifesciencesIndia | 5 September 2007 |
| 100 tablet, film coated in 1 bottle | 65862-144-01 | Aurobindo PharmaIndia | 5 September 2007 |
| 500 tablet, film coated in 1 bottle | 65862-144-05 | Aurobindo PharmaIndia | 5 September 2007 |
| 1000 tablet, film coated in 1 bottle | 65862-144-99 | Aurobindo PharmaIndia | 5 September 2007 |
| 100 tablet, film coated in 1 bottle | 55111-254-01 | Dr. Reddy's LaboratoriesIndia | 5 September 2007 |
| 500 tablet, film coated in 1 bottle | 55111-254-05 | Dr. Reddy's LaboratoriesIndia | 5 September 2007 |
| 1000 tablet, film coated in 1 bottle | 55111-254-10 | Dr. Reddy's LaboratoriesIndia | 5 September 2007 |
| 30 tablet, film coated in 1 bottle | 55111-254-30 | Dr. Reddy's LaboratoriesIndia | 5 September 2007 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 55111-254-78 | Dr. Reddy's LaboratoriesIndia | 5 September 2007 |
| 100 tablet, film coated in 1 bottle | 68462-164-01 | Glenmark PharmaceuticalsIndia | 5 September 2007 |
| 500 tablet, film coated in 1 bottle | 68462-164-05 | Glenmark PharmaceuticalsIndia | 5 September 2007 |
| 1000 tablet, film coated in 1 bottle | 68462-164-10 | Glenmark PharmaceuticalsIndia | 5 September 2007 |
| 180 tablet, film coated in 1 bottle | 68462-164-18 | Glenmark PharmaceuticalsIndia | 10 December 2014 |
| 60 tablet, film coated in 1 bottle | 68462-164-60 | Glenmark PharmaceuticalsIndia | 5 September 2007 |
| 100 tablet, film coated in 1 bottle, plastic | 76385-112-01 | Unichem LaboratoriesIndia | 1 October 2016 |
| 500 tablet, film coated in 1 bottle, plastic | 76385-112-50 | Unichem LaboratoriesIndia | 1 October 2016 |
| 1000 tablet, film coated in 1 bottle | 72888-036-00 | Advagen Pharma | 29 July 2021 |
| 100 tablet, film coated in 1 bottle | 72888-036-01 | Advagen Pharma | 29 July 2021 |
| 500 tablet, film coated in 1 bottle | 72888-036-05 | Advagen Pharma | 29 July 2021 |
| 30 tablet, film coated in 1 bottle | 72888-036-30 | Advagen Pharma | 29 July 2021 |
| 100 tablet, film coated in 1 bottle, plastic | 72888-501-01 | Advagen Pharma | 17 September 2025 |
| 500 tablet, film coated in 1 bottle, plastic | 72888-501-02 | Advagen Pharma | 17 September 2025 |
| 1000 tablet, film coated in 1 bottle, plastic | 72888-501-03 | Advagen Pharma | 17 September 2025 |
| 100 tablet, film coated in 1 bottle, plastic | 58657-752-01 | Method Pharmaceuticals | 3 December 2024 |
| 500 tablet, film coated in 1 bottle, plastic | 58657-752-50 | Method Pharmaceuticals | 3 December 2024 |
| 100 tablet, film coated in 1 bottle | 0093-7295-01 | Teva Pharmaceuticals | 6 September 2007 |
| 500 tablet, film coated in 1 bottle | 0093-7295-05 | Teva Pharmaceuticals | 2 December 2008 |
| 30 tablet, film coated in 1 bottle | 71335-1533-1 | Bryant Ranch Prepack | 10 August 2011 |
| 60 tablet, film coated in 1 bottle | 71335-1533-2 | Bryant Ranch Prepack | 10 August 2011 |
| 100 tablet, film coated in 1 bottle | 71335-1533-3 | Bryant Ranch Prepack | 10 August 2011 |
| 90 tablet, film coated in 1 bottle | 71335-1533-4 | Bryant Ranch Prepack | 10 August 2011 |
| 120 tablet, film coated in 1 bottle | 71335-1533-5 | Bryant Ranch Prepack | 10 August 2011 |
| 180 tablet, film coated in 1 bottle | 71335-1533-6 | Bryant Ranch Prepack | 10 August 2011 |
| 10 tablet, film coated in 1 bottle | 71335-1533-7 | Bryant Ranch Prepack | 5 June 2026 |
| 30 tablet, film coated in 1 bottle | 71335-1545-1 | Bryant Ranch Prepack | 30 March 2010 |
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 14 September 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 Carvedilol 12.5 mg tablet.
Other strengths and forms of Carvedilol
Clinical summary
Carvedilol is an alpha-adrenergic blocker. It is available as tablets and extended-release capsules for oral use. MedsAcross supplies Carvedilol 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 CarvedilolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Coreg prescribing information (Waylis Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Carvedilol 12.5 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.