Trintellix
These highlights do not include all the information needed to use TRINTELLIX safely and effectively. See full prescribing information for TRINTELLIX. TRINTELLIX (vortioxetine) tablets, for oral use Initial U.S. Approval: 2013
Approved
Approval ID
1a5b68e2-14d0-419d-9ec6-1ca97145e838
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
vortioxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64764-720
Application NumberNDA204447
Product Classification
M
Marketing Category
C73594
G
Generic Name
vortioxetine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (10)
VORTIOXETINE HYDROBROMIDEActive
Quantity: 5 mg in 1 1
Code: TKS641KOAY
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
vortioxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64764-750
Application NumberNDA204447
Product Classification
M
Marketing Category
C73594
G
Generic Name
vortioxetine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (10)
VORTIOXETINE HYDROBROMIDEActive
Quantity: 20 mg in 1 1
Code: TKS641KOAY
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
vortioxetine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64764-730
Application NumberNDA204447
Product Classification
M
Marketing Category
C73594
G
Generic Name
vortioxetine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (10)
VORTIOXETINE HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: TKS641KOAY
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT