AUVELITY is a Oral Tablet, Multilayer, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Axsome Therapeutics, Inc.. The primary component is Bupropion Hydrochloride; Dextromethorphan Hydrobromide.
| Product ID | 81968-045_2a8f1d11-4605-4bde-906f-e99165721141 |
| NDC | 81968-045 |
| Product Type | Human Prescription Drug |
| Proprietary Name | AUVELITY |
| Generic Name | Dextromethorphan Hydrobromide, Bupropion Hydrochloride |
| Dosage Form | Tablet, Multilayer, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-08-18 |
| Marketing Category | NDA / |
| Application Number | NDA215430 |
| Labeler Name | Axsome Therapeutics, Inc. |
| Substance Name | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE |
| Active Ingredient Strength | 105 mg/1; mg/1 |
| Pharm Classes | Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-08-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AUVELITY 90450929 not registered Live/Pending |
Axsome Therapeutics, Inc. 2021-01-06 |