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  5. NDC Package Code: 53002-1508-3 Bupropion Hydrochloride (xl)

NDC Package 53002-1508-3 Bupropion Hydrochloride (xl)

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
53002-1508-3
Package Description:
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
53002-1508
Proprietary Name:
Bupropion Hydrochloride (xl)
Usage Information:
Bupropion hydrochloride extended-release tablets (XL) is 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)].
11-Digit NDC Billing Format:
53002150803
NDC to RxNorm Crosswalk:
  • RxCUI: 993557 - buPROPion HCl 300 MG 24HR Extended Release Oral Tablet
  • RxCUI: 993557 - 24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet
  • RxCUI: 993557 - bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet
    • Labeler Name:
    Rpk Pharmaceuticals, Inc.
    Sample Package:
    No
    Start Marketing Date:
    01-08-2018
    Listing Expiration Date:
    12-31-2022
    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.

    Frequently Asked Questions

    What is NDC 53002-1508-3?

    The NDC Packaged Code 53002-1508-3 is assigned to a package of 30 tablet, extended release in 1 bottle of Bupropion Hydrochloride (xl), labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

    Is NDC 53002-1508 included in the NDC Directory?

    No, Bupropion Hydrochloride (xl) with product code 53002-1508 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rpk Pharmaceuticals, Inc. on January 08, 2018 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53002-1508-3?

    The 11-digit format is 53002150803. 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
    5-4-153002-1508-35-4-253002-1508-03