Medicine
Carvedilol 10 mg extended-release capsule
Carvedilol 10 mg extended-release capsule is a generic prescription medicine for oral use, made by 8 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).
Key facts
- Active ingredient (INN)
- Carvedilol
- Brand
- Sold under the generic name
- Strength
- 10 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 30 capsules, 100 capsules, 1000 capsules and 12 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAmneal Pharmaceuticals NYAmneal Pharmaceuticals of New YorkBryant Ranch PrepackAvKARECouplerGolden State Medical SupplyNorthStar RxLLC
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- 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
- 25 October 2017
- Identifiers
- RxCUI 860510, 860516, 860522 +1DailyMed set ID a9314bc0-fd5d-477b-bef5-3bee532774c0, fa6b4014-e9d7-4074-95fc-4b48d91da83b, 1be1b5d2-eb2c-1d02-e063-6294a90adbba +5NDC 57664-663, 0115-1248, 42291-479 +5Application ANDA090132, ANDA204717
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 capsule, extended release in 1 bottle, plastic | 57664-663-83 | Sun Pharmaceutical IndustriesIndia | 8 November 2017 |
| 100 capsule, extended release in 1 bottle | 69238-2577-1 | Amneal Pharmaceuticals NY | 1 August 2023 |
| 1000 capsule, extended release in 1 bottle | 69238-2577-2 | Amneal Pharmaceuticals NY | 1 August 2023 |
| 30 capsule, extended release in 1 bottle | 69238-2577-3 | Amneal Pharmaceuticals NY | 1 August 2023 |
| 90 capsule, extended release in 1 bottle | 69238-2577-9 | Amneal Pharmaceuticals NY | 1 August 2023 |
| 100 capsule, extended release in 1 bottle | 0115-1248-01 | Amneal Pharmaceuticals of New York | 1 January 2024 |
| 1000 capsule, extended release in 1 bottle | 0115-1248-03 | Amneal Pharmaceuticals of New York | 1 January 2024 |
| 30 capsule, extended release in 1 bottle | 0115-1248-08 | Amneal Pharmaceuticals of New York | 1 January 2024 |
| 90 capsule, extended release in 1 bottle | 0115-1248-10 | Amneal Pharmaceuticals of New York | 1 January 2024 |
| 30 capsule, extended release in 1 bottle | 42291-479-30 | AvKARE | 27 June 2024 |
| 30 capsule, extended release in 1 bottle, plastic | 71335-0308-1 | Bryant Ranch Prepack | 22 September 2023 |
| 90 capsule, extended release in 1 bottle, plastic | 71335-0308-2 | Bryant Ranch Prepack | 22 September 2023 |
| 30 capsule, extended release in 1 blister pack | 67046-1551-3 | Coupler | 9 April 2025 |
| 30 capsule, extended release in 1 bottle, plastic | 51407-050-30 | Golden State Medical Supply | 16 February 2018 |
| 30 capsule, extended release in 1 bottle, plastic | 16714-227-01 | NorthStar RxLLC | 22 July 2021 |
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 10 mg extended-release capsule.
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 10 mg extended-release 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.