Prescription drug · NDA
Trintellix (vortioxetine) NDC 70518-4483
Vortioxetine hydrobromide 5 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4483-0 | 70518448300 | 30 POUCH in 1 BOX (70518-4483-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4483-1)Marketed from Sep 24, 2025 | |
| 70518-4483-2 | 70518448302 | 50 POUCH in 1 BOX (70518-4483-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4483-1)Marketed from Apr 23, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Trintellix
- Generic name (nonproprietary)
- vortioxetine
- Active ingredients
- Vortioxetine hydrobromide — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204447
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4483_50254973-3e27-33a6-e063-6294a90aea61SPL ID 50254973-3e27-33a6-e063-6294a90aea61SPL set ID bd0107e5-1cb9-4b40-a6af-fa65fcbe6b4eRxCUI 1439812, 1790892UNII TKS641KOAY
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470518448300followed by a unit qualifier and the quantityPackage 70518-4483-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under NDA 204447
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Trintellixvortioxetine | Vortioxetine hydrobromide 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4284 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0257 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0256 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 5 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-720 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 10 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-730 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 20 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-750 |