FDA Orange Book
Generic for Coreg
Coreg contains carvedilol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Coreg is carvedilol. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Coreg products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12.5MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 25MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 3.125MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 6.25MG | Marketed (Rx) | AB | 10 | AB |
NDA 020297, held by WAYLIS THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carvedilol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 078332 | AB (A-rated, therapeutically equivalent) | September 5, 2007 | 12.5MG, 25MG, 3.125MG, 6.25MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 077474 | AB (A-rated, therapeutically equivalent) | September 5, 2007 | 12.5MG, 25MG, 3.125MG, 6.25MG |
| GLENMARK PHARMACEUTICALS LTD | 078251 | AB (A-rated, therapeutically equivalent) | September 5, 2007 | 12.5MG, 25MG, 3.125MG, 6.25MG |
| REGCON HOLDINGS LLC | 078384 | AB (A-rated, therapeutically equivalent) | September 5, 2007 | 12.5MG, 25MG, 3.125MG, 6.25MG |
| RISING PHARMA HOLDINGS INC | 076649 | AB (A-rated, therapeutically equivalent) | September 5, 2007 | 12.5MG, 25MG, 3.125MG, 6.25MG |
| RUBICON RESEARCH LTD | 078165 | AB (A-rated, therapeutically equivalent) | September 5, 2007 | 12.5MG, 25MG, 3.125MG, 6.25MG |
| SANDOZ INC | 078227 | AB (A-rated, therapeutically equivalent) | September 5, 2007 | 12.5MG, 25MG, 3.125MG, 6.25MG |
| TEVA PHARMACEUTICALS USA INC | 076373 | AB (A-rated, therapeutically equivalent) | September 5, 2007 | 12.5MG, 25MG, 3.125MG, 6.25MG |
| ZYDUS PHARMACEUTICALS USA INC | 077614 | AB (A-rated, therapeutically equivalent) | September 5, 2007 | 12.5MG, 25MG, 3.125MG, 6.25MG |
| MLV PHARMA LLC | 078786 | AB (A-rated, therapeutically equivalent) | December 22, 2009 | 12.5MG, 25MG, 3.125MG, 6.25MG |
Coreg NDC codes
Questions
Is there a generic for Coreg?
Yes. The generic name for Coreg is carvedilol. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Coreg?
The active ingredient in Coreg is carvedilol, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.