Vardenafil is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Vardenafil Hydrochloride Trihydrate.
| Product ID | 46708-235_588986f3-fd56-4f35-84b3-fa5a50e2681f |
| NDC | 46708-235 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Vardenafil |
| Generic Name | Vardenafil |
| Dosage Form | Tablet, Orally Disintegrating |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-11-20 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208324 |
| Labeler Name | Alembic Pharmaceuticals Limited |
| Substance Name | VARDENAFIL HYDROCHLORIDE TRIHYDRATE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2018-11-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208324 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-11-20 |
| Ingredient | Strength |
|---|---|
| VARDENAFIL HYDROCHLORIDE TRIHYDRATE | 10 mg/1 |
| SPL SET ID: | dce0b31b-4522-4cb4-9dba-3aea2b2bb082 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 33342-203 | Vardenafil | Vardenafil |
| 46708-235 | Vardenafil | Vardenafil |
| 51407-174 | VARDENAFIL | VARDENAFIL |
| 62332-235 | Vardenafil | Vardenafil |
| 70710-1068 | VARDENAFIL | VARDENAFIL |
| 70710-1069 | VARDENAFIL | VARDENAFIL |
| 70710-1070 | VARDENAFIL | VARDENAFIL |
| 70710-1071 | VARDENAFIL | VARDENAFIL |
| 70771-1047 | VARDENAFIL | VARDENAFIL |
| 70771-1048 | VARDENAFIL | VARDENAFIL |
| 70771-1049 | VARDENAFIL | VARDENAFIL |
| 70771-1050 | VARDENAFIL | VARDENAFIL |
| 71610-477 | VARDENAFIL | VARDENAFIL |
| 71610-643 | VARDENAFIL | VARDENAFIL |