What is NDC 72189-598?

72189-598 is the product NDC for Lurasidone HCL, Lurasidone hydrochloride 40 mg/1 tablet, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_rx, NDC labeler code 72189. 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 HCL?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lurasidone HCL NDC 72189-598 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-598Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0598Add 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
72189-598-30	72189059830	30 TABLET in 1 BOTTLE (72189-598-30)Marketed from Dec 16, 2024

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 HCL
Generic name (nonproprietary): lurasidone hcl
Active ingredients: Lurasidone hydrochloride — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct_rxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208045
Marketing start: Dec 16, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-598_296811cf-cba9-16c2-e063-6294a90acfa6SPL ID 296811cf-cba9-16c2-e063-6294a90acfa6SPL set ID 296811cf-cba8-16c2-e063-6294a90acfa6RxCUI 1040031UNII 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

N472189059830 followed by a unit qualifier and the quantity

Package 72189-0598-30. 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 16, 2024. 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)].

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-598

What is NDC 72189-598?: 72189-598 is the product NDC for Lurasidone HCL, Lurasidone hydrochloride 40 mg/1 tablet, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lurasidone HCL.
What is the active ingredient?: Lurasidone hydrochloride.
Who is the labeler?: Direct_rx, NDC labeler code 72189. 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 HCL?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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 60 mg/1	TabletOral	Coupler LLC	67046-1654
Lurasidone Hydrochloride	Lurasidone hydrochloride 20 mg/1	TabletOral	Proficient Rx LP	82804-215