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  5. NDC Package Code: 65862-955-15 Lurasidone Hydrochloride

NDC Package 65862-955-15 Lurasidone Hydrochloride

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
65862-955-15
Package Description:
1500 TABLET in 1 BAG
Product Code:
65862-955
Proprietary Name:
Lurasidone Hydrochloride
Non-Proprietary Name:
Lurasidone Hydrochloride
Substance Name:
Lurasidone Hydrochloride
Usage Information:
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)].
11-Digit NDC Billing Format:
65862095515
NDC to RxNorm Crosswalk:
  • RxCUI: 1040031 - lurasidone HCl 40 MG Oral Tablet
  • RxCUI: 1040031 - lurasidone hydrochloride 40 MG Oral Tablet
  • RxCUI: 1040041 - lurasidone HCl 80 MG Oral Tablet
  • RxCUI: 1040041 - lurasidone hydrochloride 80 MG Oral Tablet
  • RxCUI: 1235247 - lurasidone HCl 20 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LURASIDONE HYDROCHLORIDE 60 mg/1
  • LURASIDONE HYDROCHLORIDE 60 mg/1
    • Pharmacologic Class(es):
  • Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    N/A
    FDA Application Number:
    ANDA208045
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-10-2023
    Listing Expiration Date:
    12-31-2024
    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
    65862-955-05500 TABLET in 1 BOTTLE
    65862-955-3030 TABLET in 1 BOTTLE
    65862-955-9090 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-955-15?

    The NDC Packaged Code 65862-955-15 is assigned to a package of 1500 tablet in 1 bag of Lurasidone Hydrochloride, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 65862-955 included in the NDC Directory?

    Yes, Lurasidone Hydrochloride with product code 65862-955 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on March 10, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65862-955-15?

    The 11-digit format is 65862095515. 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
    5-3-265862-955-155-4-265862-0955-15