Prescription drug · NDA
Trintellix (Vortioxetine) NDC 55154-0256
Vortioxetine hydrobromide 10 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-0256-8 | 5515402560855154025608 | 2520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8)Marketed from Oct 2, 2013 |
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
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204447
- Marketing start
- Listing expires
- Identifiers
- Product ID 55154-0256_7b53e0ea-8161-474c-b623-734841128a9aSPL ID 7b53e0ea-8161-474c-b623-734841128a9aSPL set ID cb1e9df4-dd74-4073-9d78-bb55593dd000RxCUI 1439808, 1439810, 1790886, 1790890UNII TKS641KOAYUPC 0355154025783, 0355154025684
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
N455154025608followed by a unit qualifier and the quantityPackage 55154-0256-08. 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 55154-0256
- What is NDC 55154-0256?
- 55154-0256 is the product NDC for Trintellix (vortioxetine), Vortioxetine hydrobromide 10 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, 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?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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 | REMEDYREPACK INC. | 70518-4284 | 70518-4284-0070518-4284-02 |
| 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 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 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4284 |
| Trintellixvortioxetine | Vortioxetine hydrobromide 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4483 |