Trintellix
- Product NDC
- 70518-4483
- 11-digit product format
- 705184483
- Labeler code
- 70518
- Product ID
- 70518-4483_50254973-3e27-33a6-e063-6294a90aea61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vortioxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA204447
- Marketing category
- NDA
- Marketing start
- 2025-09-24
- Substance
- VORTIOXETINE HYDROBROMIDE
- Active strength
- 5 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| Ingredient | Strength |
|---|
| VORTIOXETINE HYDROBROMIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TKS641KOAY |
| Rxcui | 1439812, 1790892 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4483-0 | Trintellix | 30 in 1 BOX | TABLET, FILM COATED | 30 | | 2 |
| 70518-4483-1 | Trintellix | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 2 |
| 70518-4483-2 | Trintellix | 50 in 1 BOX | TABLET, FILM COATED | 50 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4483-0 | 70518448300 | 30 POUCH in 1 BOX (70518-4483-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4483-1) | 30 pouch | 2025-09-24 | No | No | Historical |
| 70518-4483-1 | 70518448301 | 1 in 1 POUCH | | | | | Historical |
| 70518-4483-2 | 70518448302 | 50 POUCH in 1 BOX (70518-4483-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4483-1) | 50 pouch | 2026-04-23 | No | No | Historical |