Lurasidone Hydrochloride Tablet, Film Coated
NDC Package 33342-421-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lurasidone Hydrochloride tablets is lurasidone hydrochloride is indicated for: • Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-421 and is authorized under FDA application ANDA212124.

Identification & Billing

NDC Package Code
33342-421-07
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
33342-421
11-Digit Billing Format
33342042107
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lurasidone Hydrochloride
Non-Proprietary Name
Lurasidone Hydrochloride
Substance Name
Lurasidone Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LURASIDONE HYDROCHLORIDE 60 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
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 (other indication) [see Clinical Studies (14.2)]. • Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (other indication) [see Clinical Studies (14.2)].

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA212124
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-09-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (33342-421). Click a package code to view its specific billing and regulatory data.

33342-421-10
90 TABLET, FILM COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 33342-421-07 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Lurasidone Hydrochloride, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet, film coated is formulated for oral use and contains lurasidone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Macleods Pharmaceuticals Limited on June 09, 2023. The current certification is valid through December 31, 2027.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342042107. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
33342-421-07
11-Digit CMS (5-4-2)
33342-0421-07

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.