Trintellix

Product NDC
55154-0256
11-digit product format
551540256
Labeler code
55154
Product ID
55154-0256_7b53e0ea-8161-474c-b623-734841128a9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vortioxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trintellix
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORTIOXETINE HYDROBROMIDE10 mg/1

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8a388422-f384-7ff0-47d8-9117c6bfccfaProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-0256-8Trintellix2520 in 1 BOTTLE, PLASTICTABLET, FILM COATED252021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-0256-8EA - Each55154-025694d64a9a-52f9-46ac-afb1-94f333e47c3d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-0256TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]19Current NDC, Legacy NDC, 1 package rows20250309_cb1e9df4-dd74-4073-9d78-bb55593dd000.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-0256-8551540256082520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8) 2013-10-020000-00-00NoNoCurrent