| NDC Code | 81968-045-60 |
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| Package Description | 60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60) |
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| Product NDC | 81968-045 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Auvelity |
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| Non-Proprietary Name | Dextromethorphan Hydrobromide, Bupropion Hydrochloride |
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| Dosage Form | TABLET, MULTILAYER, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20220818 |
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| Marketing Category Name | NDA |
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| Application Number | NDA215430 |
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| Manufacturer | Axsome Therapeutics, Inc. |
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| Substance Name | BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE |
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| Strength | 105; 45 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy 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] |
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