FDA.reportPublic FDA data

Trintellix

Product NDC
64764-730
11-digit product format
647640730
Labeler code
64764
Product ID
64764-730_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
10 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 HYDROBROMIDE10 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
64764-730-07Trintellix7 in 1 BOTTLETABLET, FILM COATED718
64764-730-07Trintellix1 in 1 CARTONTABLET, FILM COATED118
64764-730-09Trintellix30 in 1 BOTTLETABLET, FILM COATED3018
64764-730-30Trintellix30 in 1 BOTTLETABLET, FILM COATED3018
64764-730-77Trintellix500 in 1 BOTTLETABLET, FILM COATED50018
64764-730-90Trintellix90 in 1 BOTTLETABLET, FILM COATED9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-730-07EA - Each64764-7308405891e-57e2-4f58-a037-a97a479c77e112019-04-11
64764-730-30EA - Each64764-730b7f7e539-f959-41b4-85eb-f08e9ef1f1f712016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-730TRINTELLIX (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 TabletPSNcb1e9df4-dd74-4073-9d78-bb55593dd00021
1790890Trintellix (vortioxetine) 20 MG Oral TabletPSNcb1e9df4-dd74-4073-9d78-bb55593dd00021
1439808vortioxetine 10 MG Oral TabletPSNcb1e9df4-dd74-4073-9d78-bb55593dd00021
1439810vortioxetine 20 MG Oral TabletPSNcb1e9df4-dd74-4073-9d78-bb55593dd00021
1790886vortioxetine 10 MG Oral Tablet [Trintellix]SBDcb1e9df4-dd74-4073-9d78-bb55593dd00021
1790890vortioxetine 20 MG Oral Tablet [Trintellix]SBDcb1e9df4-dd74-4073-9d78-bb55593dd00021
1439808vortioxetine 10 MG Oral TabletSCDcb1e9df4-dd74-4073-9d78-bb55593dd00021
1439810vortioxetine 20 MG Oral TabletSCDcb1e9df4-dd74-4073-9d78-bb55593dd00021
1790886Trintellix 10 MG Oral TabletSYcb1e9df4-dd74-4073-9d78-bb55593dd00021
1790890Trintellix 20 MG Oral TabletSYcb1e9df4-dd74-4073-9d78-bb55593dd00021
1439808vortioxetine (as vortioxetine hydrobromide) 10 MG Oral TabletSYcb1e9df4-dd74-4073-9d78-bb55593dd00021
1439810vortioxetine (as vortioxetine hydrobromide) 20 MG Oral TabletSYcb1e9df4-dd74-4073-9d78-bb55593dd00021
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
1790886Trintellix (vortioxetine) 10 MG Oral TabletPSN239215eb-be32-4286-9677-1e5556c6cccf4
1439808vortioxetine 10 MG Oral TabletPSN239215eb-be32-4286-9677-1e5556c6cccf4
1790886vortioxetine 10 MG Oral Tablet [Trintellix]SBD239215eb-be32-4286-9677-1e5556c6cccf4
1439808vortioxetine 10 MG Oral TabletSCD239215eb-be32-4286-9677-1e5556c6cccf4
1790886Trintellix 10 MG Oral TabletSY239215eb-be32-4286-9677-1e5556c6cccf4
1439808vortioxetine (as vortioxetine hydrobromide) 10 MG Oral TabletSY239215eb-be32-4286-9677-1e5556c6cccf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-730-07647640730071 BOTTLE in 1 CARTON (64764-730-07) / 7 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-10-020000-00-00NoNoCurrent
64764-730-096476407300930 TABLET, FILM COATED in 1 BOTTLE (64764-730-09) 2013-10-020000-00-00NoNoCurrent
64764-730-306476407303030 TABLET, FILM COATED in 1 BOTTLE (64764-730-30) 2013-10-020000-00-00NoNoCurrent
64764-730-7764764073077500 TABLET, FILM COATED in 1 BOTTLE (64764-730-77) 2013-10-020000-00-00NoNoCurrent
64764-730-906476407309090 TABLET, FILM COATED in 1 BOTTLE (64764-730-90) 2013-10-020000-00-00NoNoCurrent