NDC 68382-969
Roflumilast
Roflumilast
Roflumilast is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Roflumilast.
| Product ID | 68382-969_986a85d7-bfd2-4b9d-85b7-d7e6f9f669fe |
| NDC | 68382-969 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Roflumilast |
| Generic Name | Roflumilast |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-10-03 |
| Marketing Category | ANDA / |
| Application Number | ANDA208303 |
| Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
| Substance Name | ROFLUMILAST |
| Active Ingredient Strength | 500 ug/1 |
| Pharm Classes | Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |