Medicine
Coreg CR 80 mg extended-release capsule
Coreg CR 80 mg extended-release capsule is a prescription medicine containing Carvedilol for oral use, marketed by Waylis Therapeutics, 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 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Carvedilol
- Brand
- Coreg CR
- Strength
- 80 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 30 capsules
- Marketing authorisation holder
- Waylis Therapeutics
- Manufacturer
- Waylis Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions 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
- C07AG02 Carvedilol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 November 2022
- Identifiers
- RxCUI 860510, 860512, 860516 +5DailyMed set ID d3625d78-6eb6-41fe-8f6f-664965c104c4NDC 80725-388Application NDA022012
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 |
|---|---|---|---|
| 30 capsule, extended release in 1 bottle, plastic | 80725-388-13 | Waylis Therapeutics | 7 November 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 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 80 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 Coreg CR 80 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.