Prescription drug · NDA
Trintellix (Vortioxetine) NDC 70518-4284
Vortioxetine hydrobromide 10 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4284-0 | 7051842840070518428400 | 30 POUCH in 1 BOX (70518-4284-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4284-1)Marketed from Feb 11, 2025 | |
| 70518-4284-2 | 7051842840270518428402 | 50 POUCH in 1 BOX (70518-4284-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4284-1)Marketed from Apr 22, 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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204447
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4284_50249818-e49f-9873-e063-6394a90ac7d9SPL ID 50249818-e49f-9873-e063-6394a90ac7d9SPL set ID 239215eb-be32-4286-9677-1e5556c6cccfRxCUI 1439808, 1790886UNII 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
N470518428400followed by a unit qualifier and the quantityPackage 70518-4284-00. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 , 14 ).
Excerpt only. Read the full label for complete information.
About NDC 70518-4284
- What is NDC 70518-4284?
- 70518-4284 is the product NDC for Trintellix (vortioxetine), Vortioxetine hydrobromide 10 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trintellix (Vortioxetine).
- What is the active ingredient?
- Vortioxetine hydrobromide.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trintellix?
- 6 other product NDCs are listed under this name. See all Trintellix NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trintellix products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trintellixvortioxetine | Vortioxetine hydrobromide 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4483 | 70518-4483-0070518-4483-02 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0256 | 55154-0256-08 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0257 | 55154-0257-08 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 5 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-720 | 64764-0720-0764764-0720-0964764-0720-30+2 more |
| Trintellixvortioxetine | Vortioxetine hydrobromide 10 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-730 | 64764-0730-0764764-0730-0964764-0730-30+2 more |
| Trintellixvortioxetine | Vortioxetine hydrobromide 20 mg/1 | Tablet, Film coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-750 | 64764-0750-0764764-0750-0964764-0750-30+2 more |
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 | Cardinal Health 107, LLC | 55154-0256 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0257 |
| 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 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4483 |