NDC 81968-045

AUVELITY

Dextromethorphan Hydrobromide, Bupropion Hydrochloride

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 ID81968-045_2a8f1d11-4605-4bde-906f-e99165721141
NDC81968-045
Product TypeHuman Prescription Drug
Proprietary NameAUVELITY
Generic NameDextromethorphan Hydrobromide, Bupropion Hydrochloride
Dosage FormTablet, Multilayer, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-08-18
Marketing CategoryNDA /
Application NumberNDA215430
Labeler NameAxsome Therapeutics, Inc.
Substance NameBUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength105 mg/1; mg/1
Pharm ClassesAminoketone [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 FlagN
Listing Certified Through2023-12-31

Packaging

NDC 81968-045-30

30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30)
Marketing Start Date2022-08-18
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [AUVELITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AUVELITY
AUVELITY
90450929 not registered Live/Pending
Axsome Therapeutics, Inc.
2021-01-06

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