What is NDC 0904-7425?

0904-7425 is the product NDC for lurasidone hydrochloride, Lurasidone hydrochloride 120 mg/1 tablet, film coated, listed with the FDA by MAJOR PHARMACEUTICALS. It has 1 package NDC, shown above in 10- and 11-digit form.

MAJOR PHARMACEUTICALS, NDC labeler code 0904. 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 0904-7425

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7425Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7425Add 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
0904-7425-46	00904742546	30 TABLET, FILM COATED in 1 BOTTLE (0904-7425-46)Marketed from Jan 5, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: MAJOR PHARMACEUTICALSNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208037
Marketing start: Feb 9, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 0904-7425_cecfd4c8-bff3-44fa-b360-b3e8a8e955f5SPL ID cecfd4c8-bff3-44fa-b360-b3e8a8e955f5SPL set ID cecfd4c8-bff3-44fa-b360-b3e8a8e955f5RxCUI 1040031, 1040041, 1235247, 1297278, 1431235UNII O0P4I5851IUPC 0309047422463, 0309047423460, 0309047424467, 0309047425464, 0309047421466
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

N400904742546 followed by a unit qualifier and the quantity

Package 00904-7425-46. 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 Dec 28, 2023. 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) ( …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-7425

What is NDC 0904-7425?: 0904-7425 is the product NDC for lurasidone hydrochloride, Lurasidone hydrochloride 120 mg/1 tablet, film coated, listed with the FDA by MAJOR PHARMACEUTICALS. 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?: MAJOR PHARMACEUTICALS, NDC labeler code 0904. 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 208037

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

FDA NDC Directory listings under ANDA 208037
Product	Strength	Form · route	Labeler	Product NDC
lurasidone hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, Film coatedOral	MAJOR PHARMACEUTICALS	0904-7421
lurasidone hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, Film coatedOral	MAJOR PHARMACEUTICALS	0904-7422
lurasidone hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	MAJOR PHARMACEUTICALS	0904-7423
lurasidone hydrochloride	Lurasidone hydrochloride 80 mg/1	Tablet, Film coatedOral	MAJOR PHARMACEUTICALS	0904-7424
lurasidone hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-207
lurasidone hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-208
lurasidone hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-209
lurasidone hydrochloride	Lurasidone hydrochloride 80 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-210
lurasidone hydrochloride	Lurasidone hydrochloride 120 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-211