Drug
Who makes darifenacin hydrobromide?
2 companies list darifenacin hydrobromide as a human prescription drug. Forms: tablet, extended release. 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 darifenacin hydrobromide
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| CIPLA PHARMACEUTICALS LIMITEDIndia | tablet, extended release | ANDAANDA207664 | 2 | 7 |
| POLYGEN PHARMACEUTICALS INC.United States | tablet, extended release | ANDAANDA211045 | 2 | 1 |
Bulk ingredient listings
- Assia Chemical Industries Ltd. - Teva Tech SiteIsrael · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- MSN Pharmachem Private LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes darifenacin hydrobromide?
- 2 companies list darifenacin hydrobromide as a human prescription drug in the openFDA NDC Directory, led by CIPLA PHARMACEUTICALS LIMITED, POLYGEN PHARMACEUTICALS INC.. 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 darifenacin hydrobromide?
- 2 companies list darifenacin hydrobromide under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies darifenacin hydrobromide active ingredient?
- 6 companies list darifenacin hydrobromide as a bulk ingredient, including Assia Chemical Industries Ltd. - Teva Tech Site, Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED, FIS FABBRICA ITALIANA SINTETICI SPA.