BELSOMRA
These highlights do not include all the information needed to use BELSOMRA safely and effectively. See full prescribing information for BELSOMRA. BELSOMRA (suvorexant) tablets, for oral use, C-IV Initial U.S. Approval: 2014
Approved
Approval ID
e5b72731-1acb-45b7-9c13-290ad12d3951
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
suvorexant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-0033
Application NumberNDA204569
Product Classification
M
Marketing Category
C73594
G
Generic Name
suvorexant
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
suvorexantActive
Quantity: 10 mg in 1 1
Code: 081L192FO9
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
suvorexant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-0325
Application NumberNDA204569
Product Classification
M
Marketing Category
C73594
G
Generic Name
suvorexant
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (9)
suvorexantActive
Quantity: 15 mg in 1 1
Code: 081L192FO9
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
suvorexant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-0335
Application NumberNDA204569
Product Classification
M
Marketing Category
C73594
G
Generic Name
suvorexant
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (9)
suvorexantActive
Quantity: 20 mg in 1 1
Code: 081L192FO9
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
suvorexant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-0005
Application NumberNDA204569
Product Classification
M
Marketing Category
C73594
G
Generic Name
suvorexant
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (11)
suvorexantActive
Quantity: 5 mg in 1 1
Code: 081L192FO9
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT