NDC 80610-130
roflumilast
Roflumilast
roflumilast is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Arcutis Biotherapeutics, Inc.. The primary component is Roflumilast.
| Product ID | 80610-130_12ae3725-8b80-435d-b049-78d2b6f815d3 |
| NDC | 80610-130 |
| Product Type | Human Prescription Drug |
| Proprietary Name | roflumilast |
| Generic Name | Roflumilast |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2022-07-29 |
| Marketing Category | NDA / |
| Application Number | NDA215985 |
| Labeler Name | Arcutis Biotherapeutics, Inc. |
| Substance Name | ROFLUMILAST |
| Active Ingredient Strength | 3 mg/g |
| Pharm Classes | Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |