What is NDC 16729-350?

16729-350 is the product NDC for lurasidone hydrochloride, Lurasidone hydrochloride 120 mg/1 tablet, film coated, listed with the FDA by Accord Healthcare, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Accord Healthcare, Inc., NDC labeler code 16729. 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?

127 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 16729-350

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-350Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0350Add 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
16729-350-10	1672903501016729035010	30 TABLET, FILM COATED in 1 BOTTLE (16729-350-10)Marketed from Feb 20, 2023

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): lurasidone hydrochloride
Generic name (nonproprietary): lurasidone hydrochloride
Active ingredients: Lurasidone hydrochloride — 120 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Accord Healthcare, Inc.NDC labeler code 16729
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208049
Marketing start: Feb 20, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 16729-350_415fe396-0d31-40a9-e063-6294a90a8462SPL ID 415fe396-0d31-40a9-e063-6294a90a8462SPL set ID 7e11ec22-63c1-41a6-899c-4fe746f76bd0RxCUI 1040031, 1040041, 1235247, 1297278, 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

N416729035010 followed by a unit qualifier and the quantity

Package 16729-0350-10. 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 Oct 17, 2025. 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 is an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) Dep…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16729-350

What is NDC 16729-350?: 16729-350 is the product NDC for lurasidone hydrochloride, Lurasidone hydrochloride 120 mg/1 tablet, film coated, listed with the FDA by Accord Healthcare, Inc.. 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?: Accord Healthcare, Inc., NDC labeler code 16729. 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?: 127 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 60 mg/1	TabletOral	Coupler LLC	67046-1654	67046-1654-03
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 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 128 lurasidone hydrochloride NDCs

Other NDCs under ANDA 208049

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

FDA NDC Directory listings under ANDA 208049
Product	Strength	Form · route	Labeler	Product NDC
lurasidone hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-346
lurasidone hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-347
lurasidone hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-348
lurasidone hydrochloride	Lurasidone hydrochloride 80 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-349
lurasidone hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6438