Darifenacin is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Rising Pharma Holdings, Inc.. The primary component is Darifenacin Hydrobromide.
| Product ID | 16571-768_e2aa9544-0136-463d-a73b-1a299534446a |
| NDC | 16571-768 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Darifenacin |
| Generic Name | Darifenacin |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-09-19 |
| Marketing Category | ANDA / |
| Application Number | ANDA206743 |
| Labeler Name | Rising Pharma Holdings, Inc. |
| 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 | 2016-09-19 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0591-4375 | Darifenacin | darifenacin |
| 0591-4380 | Darifenacin | darifenacin |
| 13668-202 | Darifenacin | Darifenacin |
| 13668-203 | Darifenacin | Darifenacin |
| 16571-767 | Darifenacin | Darifenacin |
| 16571-768 | Darifenacin | Darifenacin |
| 33342-276 | Darifenacin | Darifenacin |
| 33342-277 | Darifenacin | Darifenacin |
| 46708-223 | DARIFENACIN | DARIFENACIN |
| 46708-224 | DARIFENACIN | DARIFENACIN |
| 52605-067 | Darifenacin | Darifenacin Hydrobromide |
| 52605-068 | Darifenacin | Darifenacin Hydrobromide |
| 59746-516 | darifenacin | darifenacin hydrobromide |
| 59746-517 | darifenacin | darifenacin hydrobromide |
| 62332-223 | DARIFENACIN | DARIFENACIN |
| 69097-432 | Darifenacin | Darifenacin |
| 69097-431 | Darifenacin | Darifenacin |
| 62332-224 | DARIFENACIN | DARIFENACIN |
| 65862-862 | Darifenacin | Darifenacin |
| 65862-861 | Darifenacin | Darifenacin |
| 0430-0170 | Enablex | darifenacin |
| 0430-0171 | Enablex | darifenacin |