FDA Orange Book
Generic for Actonel
Actonel contains risedronate. 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 Actonel is risedronate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Actonel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 30MG | Discontinued | None | 5 | AB |
| tablet, oral | 35MG | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | 5MG | Discontinued | None | 4 | AB |
| tablet, oral | 75MG | Discontinued | None | 2 | AB |
NDA 020835, held by ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic risedronate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 077132 | AB (A-rated, therapeutically equivalent) | October 5, 2007 | 30MG, 35MG, 5MG |
| APOTEX INC | 090877 | AB (A-rated, therapeutically equivalent) | June 10, 2014 | 150MG, 35MG, 75MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090886 | AB (A-rated, therapeutically equivalent) | June 10, 2014 | 150MG, 30MG, 35MG, 5MG, 75MG |
| TEVA PHARMACEUTICALS USA | 079215 | AB (A-rated, therapeutically equivalent) | June 13, 2014 | 150MG |
| AUROBINDO PHARMA LTD | 200296 | AB (A-rated, therapeutically equivalent) | November 30, 2015 | 30MG, 35MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 203533 | AB (A-rated, therapeutically equivalent) | December 9, 2015 | 30MG, 35MG, 5MG |
| AUROBINDO PHARMA LTD | 206768 | AB (A-rated, therapeutically equivalent) | October 21, 2016 | 150MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 205280 | AB (A-rated, therapeutically equivalent) | May 13, 2019 | 30MG, 35MG |
Actonel NDC codes
Questions
Is there a generic for Actonel?
Yes. The generic name for Actonel is risedronate. 6 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 Actonel?
The active ingredient in Actonel is risedronate, 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.