NDC 0378-1905
Roflumilast
Roflumilast
Roflumilast is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Roflumilast.
| Product ID | 0378-1905_0a917c07-edeb-44f0-a26c-8161166dc30b |
| NDC | 0378-1905 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Roflumilast |
| Generic Name | Roflumilast |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-10-19 |
| Marketing Category | ANDA / |
| Application Number | ANDA208257 |
| Labeler Name | Mylan Pharmaceuticals 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 |