What is NDC 68382-968?

68382-968 is the product NDC for Lurasidone hydrochloride, Lurasidone hydrochloride 120 mg/1 tablet, coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 68382-968

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-968Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0968Add 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
68382-968-01	68382096801	100 TABLET, COATED in 1 BOTTLE (68382-968-01)Marketed from Feb 1, 2023
68382-968-05	68382096805	500 TABLET, COATED in 1 BOTTLE (68382-968-05)Marketed from Feb 1, 2023
68382-968-06	68382096806	30 TABLET, COATED in 1 BOTTLE (68382-968-06)Marketed from Feb 1, 2023
68382-968-16	68382096816	90 TABLET, COATED in 1 BOTTLE (68382-968-16)Marketed from Feb 1, 2023
68382-968-77	68382096877	100 BLISTER PACK in 1 CARTON (68382-968-77) / 1 TABLET, COATED in 1 BLISTER PACK (68382-968-30)Marketed from Feb 1, 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, Coated
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208052
Marketing start: Feb 1, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 68382-968_5e755270-5e9a-4208-b52b-3eaeaf652902SPL ID 5e755270-5e9a-4208-b52b-3eaeaf652902SPL set ID bceb350e-4b88-4de1-9629-9629365a27a7RxCUI 1040031, 1040041, 1235247, 1297278, 1431235UNII O0P4I5851IUPC 0368382967060, 0368382968067, 0368382859068, 0368382965066
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

N468382096801 followed by a unit qualifier and the quantity

Package 68382-0968-01. 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 Jul 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Lurasidone hydrochloride is 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 ) Dep…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-968

What is NDC 68382-968?: 68382-968 is the product NDC for Lurasidone hydrochloride, Lurasidone hydrochloride 120 mg/1 tablet, coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 5 package NDCs, 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 208052

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

FDA NDC Directory listings under ANDA 208052
Product	Strength	Form · route	Labeler	Product NDC
Lurasidone hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-859
Lurasidone hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-965
Lurasidone hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-966
Lurasidone hydrochloride	Lurasidone hydrochloride 80 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-967
Lurasidone hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, CoatedOral	Zydus Lifesciences Limited	70771-1734
Lurasidone hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, CoatedOral	Zydus Lifesciences Limited	70771-1735
Lurasidone hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, CoatedOral	Zydus Lifesciences Limited	70771-1736
Lurasidone hydrochloride	Lurasidone hydrochloride 80 mg/1	Tablet, CoatedOral	Zydus Lifesciences Limited	70771-1737
Lurasidone hydrochloride	Lurasidone hydrochloride 120 mg/1	Tablet, CoatedOral	Zydus Lifesciences Limited	70771-1738