NDC Package 65757-653-40 Lybalvi

Olanzapine And Samidorphan L-malate Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65757-653-40
Package Description:
1 BOTTLE in 1 CARTON / 7 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Lybalvi
Non-Proprietary Name:
Olanzapine And Samidorphan L-malate
Substance Name:
Olanzapine; Samidorphan L-malate
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
11-Digit NDC Billing Format:
65757065340
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2570392 - OLANZapine 5 MG / samidorphan 10 MG Oral Tablet
  • RxCUI: 2570392 - olanzapine 5 MG / samidorphan 10 MG Oral Tablet
  • RxCUI: 2570392 - olanzapine 5 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG) Oral Tablet
  • RxCUI: 2570398 - LYBALVI 5 MG / 10 MG Oral Tablet
  • RxCUI: 2570398 - olanzapine 5 MG / samidorphan 10 MG Oral Tablet [Lybalvi]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alkermes, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    NDA213378
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-20-2021
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65757-653-03153846 TABLET, FILM COATED in 1 CONTAINER
    65757-653-411 BOTTLE in 1 CARTON / 7 TABLET, FILM COATED in 1 BOTTLE
    65757-653-421 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
    65757-653-441 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65757-653-40?

    The NDC Packaged Code 65757-653-40 is assigned to a package of 1 bottle in 1 carton / 7 tablet, film coated in 1 bottle of Lybalvi, a human prescription drug labeled by Alkermes, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 65757-653 included in the NDC Directory?

    Yes, Lybalvi with product code 65757-653 is active and included in the NDC Directory. The product was first marketed by Alkermes, Inc. on September 20, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65757-653-40?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 65757-653-40?

    The 11-digit format is 65757065340. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265757-653-405-4-265757-0653-40