FDA Orange Book
Generic for Rapaflo
Rapaflo contains silodosin. 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 Rapaflo is silodosin. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Rapaflo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 4MG | Discontinued | None | 10 | AB |
| capsule, oral | 8MG | Discontinued | None | 10 | AB |
NDA 022206, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic silodosin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 204726 | AB (A-rated, therapeutically equivalent) | March 31, 2017 | 4MG, 8MG |
| AJANTA PHARMA LTD | 211060 | AB (A-rated, therapeutically equivalent) | December 3, 2018 | 4MG, 8MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 209745 | AB (A-rated, therapeutically equivalent) | December 3, 2018 | 4MG, 8MG |
| LUPIN LTD | 206541 | AB (A-rated, therapeutically equivalent) | December 3, 2018 | 4MG, 8MG |
| MACLEODS PHARMACEUTICALS LTD | 211166 | AB (A-rated, therapeutically equivalent) | December 3, 2018 | 4MG, 8MG |
| MSN LABORATORIES PRIVATE LTD | 210687 | AB (A-rated, therapeutically equivalent) | December 3, 2018 | 4MG, 8MG |
| AUROBINDO PHARMA LTD | 210626 | AB (A-rated, therapeutically equivalent) | December 10, 2018 | 4MG, 8MG |
| HETERO LABS LTD UNIT V | 204793 | AB (A-rated, therapeutically equivalent) | February 14, 2020 | 4MG, 8MG |
| PHARMAZONE | 213230 | AB (A-rated, therapeutically equivalent) | January 3, 2022 | 4MG, 8MG |
| PRINSTON PHARMACEUTICAL INC | 209029 | AB (A-rated, therapeutically equivalent) | January 4, 2022 | 4MG, 8MG |
Questions
Is there a generic for Rapaflo?
Yes. The generic name for Rapaflo is silodosin. 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 Rapaflo?
The active ingredient in Rapaflo is silodosin, 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.