NDC Package 68788-7807-9 Bupropion Hydrochloride SR

Tablet, Film Coated, Extended Release 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:
68788-7807-9
Package Description:
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Bupropion Hydrochloride SR
Non-Proprietary Name:
Bupropion Hydrochloride
Substance Name:
Bupropion Hydrochloride
Usage Information:
Bupropion hydrochloride extended-release tablets (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].
11-Digit NDC Billing Format:
68788780709
Product Type:
Human Prescription Drug
Labeler Name:
Preferred Pharmaceuticals, Inc.
Dosage Form:
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA205794
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-28-2020
    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
    68788-7807-1100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    68788-7807-220 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    68788-7807-330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    68788-7807-660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    68788-7807-8120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68788-7807-9?

    The NDC Packaged Code 68788-7807-9 is assigned to a package of 90 tablet, film coated, extended release in 1 bottle, plastic of Bupropion Hydrochloride SR, a human prescription drug labeled by Preferred Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 68788-7807 included in the NDC Directory?

    Yes, Bupropion Hydrochloride SR with product code 68788-7807 is active and included in the NDC Directory. The product was first marketed by Preferred Pharmaceuticals, Inc. on October 28, 2020 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 68788-7807-9?

    The 11-digit format is 68788780709. 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
    5-4-168788-7807-95-4-268788-7807-09