FDA Orange Book
Generic for Rythmol
Rythmol contains propafenone. 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 Rythmol is propafenone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Rythmol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Discontinued | None | 3 | AB |
| tablet, oral | 225MG | Discontinued | None | 3 | AB |
| tablet, oral | 300MG | Discontinued | None | 3 | AB |
NDA 019151, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic propafenone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| STRIDES PHARMA INTERNATIONAL AG | 075938 | AB (A-rated, therapeutically equivalent) | October 17, 2002 | 150MG, 225MG, 300MG |
| ANI PHARMACEUTICALS INC | 076550 | AB (A-rated, therapeutically equivalent) | April 23, 2004 | 150MG, 225MG, 300MG |
| AUROBINDO PHARMA LTD | 202445 | AB (A-rated, therapeutically equivalent) | May 11, 2016 | 150MG, 225MG, 300MG |
Questions
Is there a generic for Rythmol?
Yes. The generic name for Rythmol is propafenone. 3 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 Rythmol?
The active ingredient in Rythmol is propafenone, 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.