NDC codes

FDA NDC Directory
Product NDC (as listed)55154-0257Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-0257Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
55154-0257-8551540257082430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0257-8)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 — 20 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 55154-0257_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

N455154025708 followed by a unit qualifier and the quantity

Package 55154-0257-08. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 204447

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 204447
ProductStrengthForm · routeLabelerProduct NDC
TrintellixvortioxetineVortioxetine hydrobromide 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4483
TrintellixvortioxetineVortioxetine hydrobromide 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4284
TrintellixvortioxetineVortioxetine hydrobromide 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0256
TrintellixvortioxetineVortioxetine hydrobromide 5 mg/1Tablet, Film coatedOralTakeda Pharmaceuticals America, Inc.64764-720
TrintellixvortioxetineVortioxetine hydrobromide 10 mg/1Tablet, Film coatedOralTakeda Pharmaceuticals America, Inc.64764-730
TrintellixvortioxetineVortioxetine hydrobromide 20 mg/1Tablet, Film coatedOralTakeda Pharmaceuticals America, Inc.64764-750

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