What is NDC 67046-1654?

67046-1654 is the product NDC for Lurasidone Hydrochloride, Lurasidone hydrochloride 60 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lurasidone Hydrochloride?

131 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lurasidone Hydrochloride NDC 67046-1654

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-1654Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-1654Add 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 NDC	11-digit (billing)	Package	Copy
67046-1654-3	67046165403	30 TABLET in 1 BLISTER PACK (67046-1654-3)Marketed from Jan 28, 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): Lurasidone Hydrochloride
Generic name (nonproprietary): lurasidone hydrochloride
Active ingredients: Lurasidone hydrochloride — 60 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208045
Marketing start: Jan 28, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 67046-1654_4973bdb9-ab5c-58eb-e063-6294a90a883eSPL ID 4973bdb9-ab5c-58eb-e063-6294a90a883eSPL set ID 4973beed-b75b-c370-e063-6394a90a26e5RxCUI 1431235UNII O0P4I5851I
Pharmacologic class: Atypical Antipsychotic

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

N467046165403 followed by a unit qualifier and the quantity

Package 67046-1654-03. 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 Jan 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1) ]. Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2) ]. Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2) ]. Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1654

What is NDC 67046-1654?: 67046-1654 is the product NDC for Lurasidone Hydrochloride, Lurasidone hydrochloride 60 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lurasidone Hydrochloride.
What is the active ingredient?: Lurasidone hydrochloride.
Who is the labeler?: Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lurasidone Hydrochloride?: 131 other product NDCs are listed under this name. See all Lurasidone Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lurasidone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lurasidone Hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	Torrent Pharmaceuticals Limited	13668-737	13668-0737-3013668-0737-90
Lurasidone Hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1659	67046-1659-03
Lurasidone Hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4563	70518-4563-00
Lurasidone Hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1637	67046-1637-03
Lurasidone Hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4491	70518-4491-00
lurasidone hydrochloride	Lurasidone hydrochloride 40 mg/1	TabletOral	REMEDYREPACK INC.	70518-4427	70518-4427-00
lurasidone hydrochloride	Lurasidone hydrochloride 80 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-624	72603-0624-01
lurasidone hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-621	72603-0621-01
lurasidone hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-622	72603-0622-01
lurasidone hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-623	72603-0623-01

All 132 Lurasidone Hydrochloride NDCs

Other NDCs under ANDA 208045

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

FDA NDC Directory listings under ANDA 208045
Product	Strength	Form · route	Labeler	Product NDC
Lurasidone Hydrochloride	Lurasidone hydrochloride 20 mg/1	TabletOral	Aurobindo Pharma Limited	65862-953
Lurasidone Hydrochloride	Lurasidone hydrochloride 40 mg/1	TabletOral	Aurobindo Pharma Limited	65862-954
Lurasidone Hydrochloride	Lurasidone hydrochloride 60 mg/1	TabletOral	Aurobindo Pharma Limited	65862-955
Lurasidone Hydrochloride	Lurasidone hydrochloride 80 mg/1	TabletOral	Aurobindo Pharma Limited	65862-956
Lurasidone Hydrochloride	Lurasidone hydrochloride 120 mg/1	TabletOral	Aurobindo Pharma Limited	65862-957
Lurasidone HCL	Lurasidone hydrochloride 40 mg/1	TabletOral	Direct_rx	72189-598
Lurasidone Hydrochloride	Lurasidone hydrochloride 20 mg/1	TabletOral	Proficient Rx LP	82804-215