FDA.reportPublic FDA data

Trintellix

Product NDC
70518-4284
11-digit product format
705184284
Labeler code
70518
Product ID
70518-4284_50249818-e49f-9873-e063-6394a90ac7d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vortioxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA204447
Marketing category
NDA
Marketing start
2025-02-11
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, 1790886

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
70518-4284-0Trintellix30 in 1 BOXTABLET, FILM COATED304
70518-4284-1Trintellix1 in 1 POUCHTABLET, FILM COATED14
70518-4284-2Trintellix50 in 1 BOXTABLET, FILM COATED504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4284TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [REMEDYREPACK INC.]1Current NDC, 3 package rows20250214_239215eb-be32-4286-9677-1e5556c6cccf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
70518-4284-07051842840030 POUCH in 1 BOX (70518-4284-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4284-1) 30 pouch2025-02-11NoNoCurrent
70518-4284-1705184284011 in 1 POUCHHistorical
70518-4284-27051842840250 POUCH in 1 BOX (70518-4284-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4284-1) 50 pouch2026-04-22NoNoCurrent