Latuda Tablet, Film Coated
NDC Package 63402-306-10
Package Information
Latuda (lurasidone hydrochloride) tablets is a medication used to treat certain mental/mood disorders (such as schizophrenia, depression associated with bipolar disorder). This formulation utilizes a tablet, film coated delivery system. Marketed by Sumitomo Pharma America, Inc., this product is identified by NDC 63402-306 and is authorized under FDA application NDA200603.
Identification & Billing
- RxCUI: 1040031 - lurasidone HCl 40 MG Oral Tablet
- RxCUI: 1040031 - lurasidone hydrochloride 40 MG Oral Tablet
- RxCUI: 1040036 - Latuda 40 MG Oral Tablet
- RxCUI: 1040036 - lurasidone hydrochloride 40 MG Oral Tablet [Latuda]
- RxCUI: 1040041 - lurasidone HCl 80 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 63402 - Sumitomo Pharma America, Inc.
- 63402-306 - Latuda
- 63402-306-10 - 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-306-01)
- 63402-306 - Latuda
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 (63402-306). Click a package code to view its specific billing and regulatory data.
* 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 63402-306-10 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack (63402-306-01) of Latuda, a human prescription drug labeled by Sumitomo Pharma America, Inc.. 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 Sumitomo Pharma America, Inc. on July 12, 2013. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is used to treat certain mental/mood disorders (such as schizophrenia, depression associated with bipolar disorder). Lurasidone helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). In addition, this medication may improve your mood, sleep, appetite, and energy level. Lurasidone is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.
How is this Sumitomo Pharma America, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 63402030610. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
