FDA Orange Book
Generic for Betapace
Betapace contains sotalol. 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 Betapace is sotalol. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Betapace products the Orange Book lists.
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Betapace products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 120MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 160MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 240MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 320MG | Discontinued | None | 0 | None |
| tablet, oral | 80MG | Marketed (Rx) | AB | 9 | AB |
NDA 019865, held by LEGACY PHARMA INC SEZC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sotalol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 075429 | AB (A-rated, therapeutically equivalent) | May 1, 2000 | 120MG, 160MG, 240MG, 80MG |
| AIPING PHARMACEUTICAL INC | 075500 | AB (A-rated, therapeutically equivalent) | April 27, 2001 | 120MG, 160MG, 240MG, 80MG |
| APOTEX INC | 076140 | AB (A-rated, therapeutically equivalent) | September 26, 2002 | 120MG, 160MG, 240MG, 80MG |
| APOTEX INC | 076214 | AB (A-rated, therapeutically equivalent) | August 27, 2003 | 120MG, 160MG, 80MG |
| OXFORD PHARMACEUTICALS LLC | 075563 | AB (A-rated, therapeutically equivalent) | November 7, 2003 | 120MG, 160MG, 240MG, 80MG |
| EPIC PHARMA LLC | 077070 | AB (A-rated, therapeutically equivalent) | November 4, 2005 | 120MG, 160MG, 80MG |
| AUROBINDO PHARMA USA INC | 077616 | AB (A-rated, therapeutically equivalent) | February 7, 2007 | 120MG, 160MG, 80MG |
| REGCON HOLDINGS LLC | 207428 | AB (A-rated, therapeutically equivalent) | October 21, 2016 | 120MG, 160MG, 80MG |
| REGCON HOLDINGS LLC | 207429 | AB (A-rated, therapeutically equivalent) | November 2, 2018 | 120MG, 160MG, 80MG |
Betapace NDC codes
Questions
Is there a generic for Betapace?
Yes. The generic name for Betapace is sotalol. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Betapace products the Orange Book lists.
What is the generic name for Betapace?
The active ingredient in Betapace is sotalol, 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.