AUVELITY
These highlights do not include all the information needed to use AUVELITY safely and effectively. See full prescribing information for AUVELITY. AUVELITY (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2022
Approved
Approval ID
dcefda7c-9a68-278e-e053-2995a90aec79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Axsome Therapeutics, Inc.
DUNS: 033333109
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dextromethorphan hydrobromide, bupropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81968-045
Application NumberNDA215430
Product Classification
M
Marketing Category
C73594
G
Generic Name
dextromethorphan hydrobromide, bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2022
FDA Product Classification
INGREDIENTS (16)
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 45 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
BUPROPION HYDROCHLORIDEActive
Quantity: 105 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GLYCERYL MONOCAPRYLATEInactive
Code: TM2TZD4G4A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Code: ZT934N0X4W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT