Drug
Who makes risedronate sodium?
10 companies list risedronate sodium as a human prescription drug, including under the names Actonel, Atelvia. Forms: tablet, delayed release; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing risedronate sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA090886 | 5 | 13 |
| Allergan, Inc.United States | tablet, delayed release; tablet, film coated | NDANDA020835, NDA022560 | 3 | 7 |
| Apotex Inc.Canada | tablet, film coated | ANDAANDA090877 | 3 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA077132 | 3 | 6 |
| Macleods Pharmaceuticals LimitedIndia | tablet, film coated | ANDAANDA203533 | 3 | 5 |
| Mylan Pharmaceuticals, Inc. | tablet, delayed release; tablet, film coated | NDA AUTHORIZED GENERICNDA020835, NDA022560 | 3 | 0 |
| Aurobindo Pharma LimitedIndia | tablet, film coated | ANDAANDA206768 | 1 | 6 |
| Hangzhou Minsheng Binjiang Pharmaceutical Co.,Ltd.China | tablet, film coated | ANDAANDA207516 | 1 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA090877 | 1 | 1 |
| Sun Pharmaceutical Industires Inc. | tablet, delayed release | ANDAANDA203925 | 1 | 0 |
Bulk ingredient listings
- Alchymars ICM SM Private LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- SYNTHIMED LABS PRIVATE LIMITEDIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- TAPI Croatia industries d.o.o.Croatia · 1 NDC
Orange Book patents
2 unexpired patents list risedronate sodium as the active ingredient, expiring between Jan 2028 and Jan 2028. Application holder: ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD.
Enquiry
Common questions
- Who makes risedronate sodium?
- 10 companies list risedronate sodium as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Allergan, Inc., Apotex Inc., Teva Pharmaceutical Industries Ltd., Macleods Pharmaceuticals Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Actonel?
- 8 companies list risedronate sodium under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies risedronate sodium active ingredient?
- 7 companies list risedronate sodium as a bulk ingredient, including Alchymars ICM SM Private Limited, CIPLA PHARMACEUTICALS LIMITED, Hetero Drugs Limited, Jubilant Biosys Limited.