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  5. NDC Package Code: 76519-1021-3 Bupropion Hydrochloride

NDC Package 76519-1021-3 Bupropion Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
76519-1021-3
Package Description:
30 TABLET, EXTENDED RELEASE in 1 CONTAINER
Product Code:
76519-1021
Proprietary Name:
Bupropion Hydrochloride
Usage Information:
1.1 Major Depressive DisorderBupropion hydrochloride extended-release tablets, (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see CLINICAL STUDIES (14.1)]. 1.2 Seasonal Affective DisorderBupropion hydrochloride extended-release tablets, (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets, (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see CLINICAL STUDIES (14.2)].
11-Digit NDC Billing Format:
76519102103
NDC to RxNorm Crosswalk:
  • RxCUI: 993541 - buPROPion HCl 150 MG 24HR Extended Release Oral Tablet
  • RxCUI: 993541 - 24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet
  • RxCUI: 993541 - bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet
    • Labeler Name:
    H.j. Harkins Company Inc.
    Sample Package:
    No
    Start Marketing Date:
    01-03-2017
    Listing Expiration Date:
    12-31-2019
    Exclude Flag:
    I
    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
    76519-1021-5150 TABLET, EXTENDED RELEASE in 1 CONTAINER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 76519-1021-3?

    The NDC Packaged Code 76519-1021-3 is assigned to a package of 30 tablet, extended release in 1 container of Bupropion Hydrochloride, labeled by H.j. Harkins Company Inc.. The product's dosage form is and is administered via form.

    Is NDC 76519-1021 included in the NDC Directory?

    No, Bupropion Hydrochloride with product code 76519-1021 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by H.j. Harkins Company Inc. on January 03, 2017 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 76519-1021-3?

    The 11-digit format is 76519102103. 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
    5-4-176519-1021-35-4-276519-1021-03