PREVYMIS
These highlights do not include all the information needed to use PREVYMIS safely and effectively. See full prescribing information for PREVYMIS. PREVYMIS (letermovir) tablets, for oral use PREVYMIS (letermovir) injection, for intravenous use Initial U.S. Approval: 2017
Approved
Approval ID
1b49df80-be4f-47e0-a0b7-123f3e69395b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 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.
LETERMOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-3076
Application NumberNDA209939
Product Classification
M
Marketing Category
C73594
G
Generic Name
LETERMOVIR
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2023
FDA Product Classification
INGREDIENTS (14)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LETERMOVIRActive
Quantity: 480 mg in 1 1
Code: 1H09Y5WO1F
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
LETERMOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-5004
Application NumberNDA209940
Product Classification
M
Marketing Category
C73594
G
Generic Name
LETERMOVIR
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 2, 2023
FDA Product Classification
INGREDIENTS (5)
LETERMOVIRActive
Quantity: 20 mg in 1 mL
Code: 1H09Y5WO1F
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 3.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 1.2 mg in 1 mL
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYPROPYL BETADEXInactive
Quantity: 150 mg in 1 mL
Code: 1I96OHX6EK
Classification: IACT
LETERMOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-3075
Application NumberNDA209939
Product Classification
M
Marketing Category
C73594
G
Generic Name
LETERMOVIR
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2023
FDA Product Classification
INGREDIENTS (13)
LETERMOVIRActive
Quantity: 240 mg in 1 1
Code: 1H09Y5WO1F
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
LETERMOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-5003
Application NumberNDA209940
Product Classification
M
Marketing Category
C73594
G
Generic Name
LETERMOVIR
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 2, 2023
FDA Product Classification
INGREDIENTS (5)
HYDROXYPROPYL BETADEXInactive
Quantity: 150 mg in 1 mL
Code: 1I96OHX6EK
Classification: IACT
LETERMOVIRActive
Quantity: 20 mg in 1 mL
Code: 1H09Y5WO1F
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 3.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Quantity: 1.2 mg in 1 mL
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT