trintellix

Generic: vortioxetine

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name trintellix
Generic Name vortioxetine
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vortioxetine hydrobromide 20 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-750
Product ID 64764-750_186fcd68-438e-427f-ae19-8042c15baa78
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204447
Listing Expiration 2026-12-31
Marketing Start 2013-10-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764750
Hyphenated Format 64764-750

Supplemental Identifiers

RxCUI
1439808 1439810 1439812 1790886 1790890 1790892
UPC
0364764720308 0364764750305 0364764730307
UNII
TKS641KOAY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name trintellix (source: ndc)
Generic Name vortioxetine (source: ndc)
Application Number NDA204447 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (64764-750-07) / 7 TABLET, FILM COATED in 1 BOTTLE
  • 30 TABLET, FILM COATED in 1 BOTTLE (64764-750-09)
  • 30 TABLET, FILM COATED in 1 BOTTLE (64764-750-30)
  • 500 TABLET, FILM COATED in 1 BOTTLE (64764-750-77)
  • 90 TABLET, FILM COATED in 1 BOTTLE (64764-750-90)
source: ndc

Packages (5)

64764-750-07 1 BOTTLE in 1 CARTON (64764-750-07) / 7 TABLET, FILM COATED in 1 BOTTLE 64764-750-09 30 TABLET, FILM COATED in 1 BOTTLE (64764-750-09) 64764-750-30 30 TABLET, FILM COATED in 1 BOTTLE (64764-750-30) 64764-750-77 500 TABLET, FILM COATED in 1 BOTTLE (64764-750-77) 64764-750-90 90 TABLET, FILM COATED in 1 BOTTLE (64764-750-90)

Ingredients (1)

vortioxetine hydrobromide (20 mg/1)

Linked Drug Pages (1)

Trintellix ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "186fcd68-438e-427f-ae19-8042c15baa78", "openfda": {"upc": ["0364764720308", "0364764750305", "0364764730307"], "unii": ["TKS641KOAY"], "rxcui": ["1439808", "1439810", "1439812", "1790886", "1790890", "1790892"], "spl_set_id": ["1a5b68e2-14d0-419d-9ec6-1ca97145e838"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (64764-750-07)  / 7 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "64764-750-07", "marketing_start_date": "20131002"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (64764-750-09)", "package_ndc": "64764-750-09", "marketing_start_date": "20131002"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (64764-750-30)", "package_ndc": "64764-750-30", "marketing_start_date": "20131002"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (64764-750-77)", "package_ndc": "64764-750-77", "marketing_start_date": "20131002"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (64764-750-90)", "package_ndc": "64764-750-90", "marketing_start_date": "20131002"}], "brand_name": "Trintellix", "product_id": "64764-750_186fcd68-438e-427f-ae19-8042c15baa78", "dosage_form": "TABLET, FILM COATED", "product_ndc": "64764-750", "generic_name": "vortioxetine", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trintellix", "active_ingredients": [{"name": "VORTIOXETINE HYDROBROMIDE", "strength": "20 mg/1"}], "application_number": "NDA204447", "marketing_category": "NDA", "marketing_start_date": "20131002", "listing_expiration_date": "20261231"}