SUNOSI
These highlights do not include all the information needed to use SUNOSI safely and effectively. See full prescribing information for SUNOSI. SUNOSI (solriamfetol) tablets, for oral use, CIV Initial U.S. Approval: 2019
Approved
Approval ID
362f206b-73e7-4009-8c34-5a9df55679ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2023
Manufacturers
FDA
Axsome Therapeutics, Inc.
DUNS: 033333109
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
solriamfetol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81968-350
Application NumberNDA211230
Product Classification
M
Marketing Category
C73594
G
Generic Name
solriamfetol
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (8)
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Quantity: 2.75 mg in 1 1
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Quantity: 0.5 mg in 1 1
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Quantity: 1.3 mg in 1 1
Code: 532B59J990
Classification: IACT
SOLRIAMFETOLActive
Quantity: 75 mg in 1 1
Code: 939U7C91AI
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 0.65 mg in 1 1
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Quantity: 0.48 mg in 1 1
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Quantity: 0.58 mg in 1 1
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Quantity: 0.23 mg in 1 1
Code: EX438O2MRT
Classification: IACT
solriamfetol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81968-351
Application NumberNDA211230
Product Classification
M
Marketing Category
C73594
G
Generic Name
solriamfetol
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (8)
SOLRIAMFETOLActive
Quantity: 150 mg in 1 1
Code: 939U7C91AI
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Quantity: 5.50 mg in 1 1
Code: UKE75GEA7F
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Quantity: 2.59 mg in 1 1
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Quantity: 1.0 mg in 1 1
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 1.31 mg in 1 1
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Quantity: 1.46 mg in 1 1
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Quantity: 0.96 mg in 1 1
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Quantity: 0.16 mg in 1 1
Code: EX438O2MRT
Classification: IACT