Darifenacin 15 mg is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Xiromed, Llc. The primary component is Darifenacin Hydrobromide.
| Product ID | 70700-183_045ab360-9ad8-5d11-f670-a97c2604cb1c |
| NDC | 70700-183 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Darifenacin 15 mg |
| Generic Name | Darifenacin Hydrobromide |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-04-30 |
| Marketing Category | ANDA / |
| Application Number | ANDA209571 |
| Labeler Name | Xiromed, LLC |
| Substance Name | DARIFENACIN HYDROBROMIDE |
| Active Ingredient Strength | 15 mg/1 |
| Pharm Classes | Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-04-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70700-183 | Darifenacin 15 mg | Darifenacin Hydrobromide |
| 71205-901 | Darifenacin 15 mg | Darifenacin Hydrobromide |
| 52605-067 | Darifenacin | Darifenacin Hydrobromide |
| 52605-068 | Darifenacin | Darifenacin Hydrobromide |
| 59746-516 | darifenacin | darifenacin hydrobromide |
| 59746-517 | darifenacin | darifenacin hydrobromide |
| 69097-431 | Darifenacin | Darifenacin Hydrobromide |
| 69097-432 | Darifenacin | Darifenacin Hydrobromide |
| 70700-182 | Darifenacin 7.5 mg | Darifenacin Hydrobromide |
| 71205-900 | Darifenacin 7.5 mg | Darifenacin Hydrobromide |
| 10370-170 | Darifenacin Hydrobromide | Darifenacin Hydrobromide |
| 10370-171 | Darifenacin Hydrobromide | Darifenacin Hydrobromide |
| 42291-206 | Darifenacin Hydrobromide | Darifenacin Hydrobromide |
| 42291-207 | Darifenacin Hydrobromide | Darifenacin Hydrobromide |
| 60429-850 | Darifenacin Hydrobromide | Darifenacin Hydrobromide |
| 60429-851 | Darifenacin Hydrobromide | Darifenacin Hydrobromide |