What is NDC 46708-498?

46708-498 is the product NDC for Lurasidone Hydrochloride, Lurasidone hydrochloride 120 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?

129 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 46708-498

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-498Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0498Add 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
46708-498-10	4670804981046708049810	100 BLISTER PACK in 1 CARTON (46708-498-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 24, 2023
46708-498-30	4670804983046708049830	30 TABLET, FILM COATED in 1 BOTTLE (46708-498-30)Marketed from Jan 24, 2023
46708-498-71	4670804987146708049871	500 TABLET, FILM COATED in 1 BOTTLE (46708-498-71)Marketed from Jan 24, 2023
46708-498-90	4670804989046708049890	90 TABLET, FILM COATED in 1 BOTTLE (46708-498-90)Marketed from Jan 24, 2023
46708-498-91	4670804989146708049891	1000 TABLET, FILM COATED in 1 BOTTLE (46708-498-91)Marketed from Jan 24, 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: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213248
Marketing start: Jan 24, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 46708-498_a4f0715d-590f-4b13-bb72-19cdca95aa01SPL ID a4f0715d-590f-4b13-bb72-19cdca95aa01SPL set ID 27f70e15-ee22-47ae-ba87-20e2b4a1a4d6RxCUI 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

N446708049810 followed by a unit qualifier and the quantity

Package 46708-0498-10. 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 Jan 25, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Lurasidone hydrochloride tablets are indicated for: 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: Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy (1,14.2) Depressive episode associated with Bipolar…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-498

What is NDC 46708-498?: 46708-498 is the product NDC for Lurasidone Hydrochloride, Lurasidone hydrochloride 120 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?: 129 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 40 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-622	72603-0622-01
lurasidone hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-621	72603-0621-01
lurasidone hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-623	72603-0623-01

All 130 Lurasidone Hydrochloride NDCs

Other NDCs under ANDA 213248

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

FDA NDC Directory listings under ANDA 213248
Product	Strength	Form · route	Labeler	Product NDC
Lurasidone Hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-494
Lurasidone Hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-495
Lurasidone Hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-496
Lurasidone Hydrochloride	Lurasidone hydrochloride 80 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-497
Lurasidone Hydrochloride	Lurasidone hydrochloride 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-494
Lurasidone Hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-495
Lurasidone Hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-496
Lurasidone Hydrochloride	Lurasidone hydrochloride 80 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-497
Lurasidone Hydrochloride	Lurasidone hydrochloride 120 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-498
Lurasidone Hydrochloride	Lurasidone hydrochloride 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1637
Lurasidone Hydrochloride	Lurasidone hydrochloride 60 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1659