NDC 43547-005
ROFLUMILAST
Roflumilast
ROFLUMILAST is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Solco Healthcare Us, Llc.. The primary component is Roflumilast.
| Product ID | 43547-005_4251c764-7224-4f94-9de7-b6c76cb1f5cd |
| NDC | 43547-005 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ROFLUMILAST |
| Generic Name | Roflumilast |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-05-10 |
| Marketing Category | ANDA / |
| Application Number | ANDA208299 |
| Labeler Name | Solco Healthcare US, LLC. |
| 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 |