Prescription drug · NDA
Trintellix (vortioxetine) NDC 64764-720
Vortioxetine hydrobromide 5 mg/1 · Tablet, Film coated · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-720-07 | 64764072007 | 1 BOTTLE in 1 CARTON (64764-720-07) / 7 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 2, 2013 | |
| 64764-720-09 | 64764072009 | 30 TABLET, FILM COATED in 1 BOTTLE (64764-720-09)Marketed from Oct 2, 2013 | |
| 64764-720-30 | 64764072030 | 30 TABLET, FILM COATED in 1 BOTTLE (64764-720-30)Marketed from Oct 2, 2013 | |
| 64764-720-77 | 64764072077 | 500 TABLET, FILM COATED in 1 BOTTLE (64764-720-77)Marketed from Oct 2, 2013 | |
| 64764-720-90 | 64764072090 | 90 TABLET, FILM COATED in 1 BOTTLE (64764-720-90)Marketed from Oct 2, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204447
- Marketing start
- Listing expires
- Identifiers
- Product ID 64764-720_186fcd68-438e-427f-ae19-8042c15baa78SPL ID 186fcd68-438e-427f-ae19-8042c15baa78SPL set ID 1a5b68e2-14d0-419d-9ec6-1ca97145e838RxCUI 1439808, 1439810, 1439812, 1790886, 1790890, 1790892UNII TKS641KOAYUPC 0364764720308, 0364764750305, 0364764730307
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
N464764072007followed by a unit qualifier and the quantityPackage 64764-0720-07. 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.
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 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4483 |
| 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 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 |