ZONTIVITY
These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY. ZONTIVITY (vorapaxar) Tablets 2.08 mg*, for oral use *Equivalent to 2.5 mg vorapaxar sulfate Initial U.S. Approval: 2014
Approved
Approval ID
f001f406-8cf1-40a4-bbf5-1775fe020122
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2021
Manufacturers
FDA
Aralez Pharmaceuticals Us Inc.
DUNS: 046550531
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
vorapaxar
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70347-208
Application NumberNDA204886
Product Classification
M
Marketing Category
C73594
G
Generic Name
vorapaxar
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2021
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
VORAPAXAR SULFATEActive
Quantity: 2.08 mg in 1 1
Code: IN66038E6C
Classification: ACTIM
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT