FDA Orange Book
Generic for Rythmol SR
Rythmol SR 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 SR is propafenone. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Rythmol SR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 225MG | Discontinued | None | 8 | AB |
| capsule, extended release, oral | 325MG | Discontinued | None | 8 | AB |
| capsule, extended release, oral | 425MG | Discontinued | None | 8 | AB |
NDA 021416, 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 | 078540 | AB (A-rated, therapeutically equivalent) | October 18, 2010 | 225MG, 325MG, 425MG |
| WATSON LABORATORIES INC | 202688 | AB (A-rated, therapeutically equivalent) | August 24, 2015 | 225MG, 325MG, 425MG |
| GLENMARK PHARMACEUTICALS LTD | 205268 | AB (A-rated, therapeutically equivalent) | September 8, 2017 | 225MG, 325MG, 425MG |
| RISING PHARMA HOLDINGS INC | 205956 | AB (A-rated, therapeutically equivalent) | July 2, 2018 | 225MG, 325MG, 425MG |
| SINOTHERAPEUTICS INC | 210339 | AB (A-rated, therapeutically equivalent) | January 4, 2019 | 225MG, 325MG, 425MG |
| UPSHER SMITH LABORATORIES LLC | 212744 | AB (A-rated, therapeutically equivalent) | June 25, 2020 | 225MG, 325MG, 425MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 214184 | AB (A-rated, therapeutically equivalent) | April 21, 2021 | 225MG, 325MG, 425MG |
| AUROBINDO PHARMA LTD | 213096 | AB (A-rated, therapeutically equivalent) | February 21, 2023 | 225MG, 325MG, 425MG |
Questions
Is there a generic for Rythmol SR?
Yes. The generic name for Rythmol SR is propafenone. 8 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 SR?
The active ingredient in Rythmol SR 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.