Quick answers
- What is Coreg CR?
- Coreg CR is a brand name of Carvedilol, a prescription medicine. The FDA NDC Directory lists 4 Coreg CR products in 4 strengths and forms.
- Who makes Coreg CR?
- Waylis Therap holds the FDA application for Coreg CR (NDA022012, approved October 20, 2006).
- Is there a generic or store brand of Coreg CR?
- Yes. The FDA NDC Directory lists 29 other products with the same active ingredients, strength and form as a Coreg CR product, 29 of them generic. Ask your pharmacist whether one is right for you.
- Has Coreg CR been recalled?
- No recall linked to Coreg CR products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Coreg CR is
Each Coreg CR product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Carvedilol · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| carvedilol phosphate 10 mg capsule, extended release (oral) | Coreg CR | 8 products, 8 companies | DailyMed |
| carvedilol phosphate 20 mg capsule, extended release (oral) | Coreg CR | 7 products, 7 companies | DailyMed |
| carvedilol phosphate 40 mg capsule, extended release (oral) | Coreg CR | 7 products, 7 companies | DailyMed |
| carvedilol phosphate 80 mg capsule, extended release (oral) | Coreg CR | 7 products, 7 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Carvedilol →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022012 | Waylis Therap | October 20, 2006 | 4 |
Companies that list Coreg CR
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Coreg CR products.
- Waylis Therapeutics LLC4 products
Recalls
No recall linked to Coreg CR products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.