trintellix

Generic: vortioxetine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

vortioxetine hydrobromide 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4483
Product ID 70518-4483_3f8c7339-73cd-5934-e063-6394a90a5d15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204447
Listing Expiration 2026-12-31
Marketing Start 2025-09-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184483
Hyphenated Format 70518-4483

Supplemental Identifiers

RxCUI
1439812 1790892
UNII
TKS641KOAY

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
  • 5 mg/1
source: ndc
Packaging
  • 30 POUCH in 1 BOX (70518-4483-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4483-1)
source: ndc

Packages (1)

70518-4483-0 30 POUCH in 1 BOX (70518-4483-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4483-1)

Ingredients (1)

vortioxetine hydrobromide (5 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": "3f8c7339-73cd-5934-e063-6394a90a5d15", "openfda": {"unii": ["TKS641KOAY"], "rxcui": ["1439812", "1790892"], "spl_set_id": ["bd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 BOX (70518-4483-0)  / 1 TABLET, FILM COATED in 1 POUCH (70518-4483-1)", "package_ndc": "70518-4483-0", "marketing_start_date": "20250924"}], "brand_name": "Trintellix", "product_id": "70518-4483_3f8c7339-73cd-5934-e063-6394a90a5d15", "dosage_form": "TABLET, FILM COATED", "product_ndc": "70518-4483", "generic_name": "vortioxetine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trintellix", "active_ingredients": [{"name": "VORTIOXETINE HYDROBROMIDE", "strength": "5 mg/1"}], "application_number": "NDA204447", "marketing_category": "NDA", "marketing_start_date": "20250924", "listing_expiration_date": "20261231"}