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  5. NDC Package Code: 70518-3762-0 Lurasidone Hydrochloride

NDC Package 70518-3762-0 Lurasidone Hydrochloride

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

Table of Contents

    1. Package Information
    2. 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:
70518-3762-0
Package Description:
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
70518-3762
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:
70518376200
NDC to RxNorm Crosswalk:
  • RxCUI: 1235247 - lurasidone HCl 20 MG Oral Tablet
  • RxCUI: 1235247 - lurasidone hydrochloride 20 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Remedyrepack 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.
    • Active Ingredient(s):
  • LURASIDONE HYDROCHLORIDE 20 mg/1
    • Pharmacologic Class(es):
  • Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA208049
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-12-2023
    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.

    Frequently Asked Questions

    What is NDC 70518-3762-0?

    The NDC Packaged Code 70518-3762-0 is assigned to a package of 30 tablet, film coated in 1 blister pack of Lurasidone Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 70518-3762 included in the NDC Directory?

    Yes, Lurasidone Hydrochloride with product code 70518-3762 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on June 12, 2023 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 11-digit format for NDC 70518-3762-0?

    The 11-digit format is 70518376200. 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 5-4-1 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
    5-4-170518-3762-05-4-270518-3762-00