FDA.reportPublic FDA data

Trintellix

Product NDC
64764-720
11-digit product format
647640720
Labeler code
64764
Product ID
64764-720_186fcd68-438e-427f-ae19-8042c15baa78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vortioxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA204447
Marketing category
NDA
Marketing start
2013-10-02
Substance
VORTIOXETINE HYDROBROMIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trintellix
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORTIOXETINE HYDROBROMIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTKS641KOAY
Rxcui1439808, 1439810, 1439812, 1790886, 1790890, 1790892

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8a388422-f384-7ff0-47d8-9117c6bfccfaProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-720-07Trintellix1 in 1 CARTONTABLET, FILM COATED118
64764-720-07Trintellix7 in 1 BOTTLETABLET, FILM COATED718
64764-720-09Trintellix30 in 1 BOTTLETABLET, FILM COATED3018
64764-720-30Trintellix30 in 1 BOTTLETABLET, FILM COATED3018
64764-720-77Trintellix500 in 1 BOTTLETABLET, FILM COATED50018
64764-720-90Trintellix90 in 1 BOTTLETABLET, FILM COATED9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-720-07EA - Each64764-72005fa4a75-be0a-40c3-a2a8-4f9bd9383d1a12019-01-24
64764-720-30EA - Each64764-720b0cf08d7-726c-481f-9406-f8d97a60adfa12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-720TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]18Current NDC, Legacy NDC, 6 package rows20250311_1a5b68e2-14d0-419d-9ec6-1ca97145e838.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790886Trintellix (vortioxetine) 10 MG Oral TabletPSN1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1790890Trintellix (vortioxetine) 20 MG Oral TabletPSN1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1790892Trintellix (vortioxetine) 5 MG Oral TabletPSN1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1439808vortioxetine 10 MG Oral TabletPSN1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1439810vortioxetine 20 MG Oral TabletPSN1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1439812vortioxetine 5 MG Oral TabletPSN1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1790886vortioxetine 10 MG Oral Tablet [Trintellix]SBD1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1790890vortioxetine 20 MG Oral Tablet [Trintellix]SBD1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1790892vortioxetine 5 MG Oral Tablet [Trintellix]SBD1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1439808vortioxetine 10 MG Oral TabletSCD1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1439810vortioxetine 20 MG Oral TabletSCD1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1439812vortioxetine 5 MG Oral TabletSCD1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1790886Trintellix 10 MG Oral TabletSY1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1790890Trintellix 20 MG Oral TabletSY1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1790892Trintellix 5 MG Oral TabletSY1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1439808vortioxetine (as vortioxetine hydrobromide) 10 MG Oral TabletSY1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1439810vortioxetine (as vortioxetine hydrobromide) 20 MG Oral TabletSY1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1439812vortioxetine (as vortioxetine hydrobromide) 5 MG Oral TabletSY1a5b68e2-14d0-419d-9ec6-1ca97145e83818
1790892Trintellix (vortioxetine) 5 MG Oral TabletPSNbd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e2
1439812vortioxetine 5 MG Oral TabletPSNbd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e2
1790892vortioxetine 5 MG Oral Tablet [Trintellix]SBDbd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e2
1439812vortioxetine 5 MG Oral TabletSCDbd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e2
1790892Trintellix 5 MG Oral TabletSYbd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e2
1439812vortioxetine (as vortioxetine hydrobromide) 5 MG Oral TabletSYbd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-720-07647640720071 BOTTLE in 1 CARTON (64764-720-07) / 7 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-10-020000-00-00NoNoCurrent
64764-720-096476407200930 TABLET, FILM COATED in 1 BOTTLE (64764-720-09) 2013-10-020000-00-00NoNoCurrent
64764-720-306476407203030 TABLET, FILM COATED in 1 BOTTLE (64764-720-30) 2013-10-020000-00-00NoNoCurrent
64764-720-7764764072077500 TABLET, FILM COATED in 1 BOTTLE (64764-720-77) 2013-10-020000-00-00NoNoCurrent
64764-720-906476407209090 TABLET, FILM COATED in 1 BOTTLE (64764-720-90) 2013-10-020000-00-00NoNoCurrent