Lybalvi Tablet, Film Coated
NDC Package 65757-652-41

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

Lybalvi (olanzapine and samidorphan l-malate) tablets is lYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment. This formulation utilizes a tablet, film coated delivery system. Marketed by Alkermes, Inc., this product is identified by NDC 65757-652 and is authorized under FDA application NDA213378.

Identification & Billing

NDC Package Code
65757-652-41
Package Description
1 BOTTLE in 1 CARTON / 7 TABLET, FILM COATED in 1 BOTTLE
Product Code
65757-652
11-Digit Billing Format
65757065241
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lybalvi
Non-Proprietary Name
Olanzapine And Samidorphan L-malate
Substance Name
Olanzapine; Samidorphan L-malate
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)
Pharmacologic Class
Usage Information
LYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment

Regulatory & Marketing

Labeler Name
Alkermes, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213378
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-20-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (65757-652). Click a package code to view its specific billing and regulatory data.

65757-652-02
192308 TABLET, FILM COATED in 1 CONTAINER
65757-652-40
1 BOTTLE in 1 CARTON / 7 TABLET, FILM COATED in 1 BOTTLE
65757-652-42
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
65757-652-44
1 BOTTLE in 1 CARTON / 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 65757-652-41 identifies a specific commercial package of 1 bottle in 1 carton / 7 tablet, film coated in 1 bottle of Lybalvi, a human prescription drug labeled by Alkermes, Inc.. This tablet, film coated is formulated for oral use and contains olanzapine; samidorphan l-malate 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 Alkermes, Inc. on September 20, 2021. The current certification is valid through December 31, 2027.

How is this Alkermes, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65757065241. 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)
65757-652-41
11-Digit CMS (5-4-2)
65757-0652-41

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