NDC Package 68788-7786-6 Bupropion Hydrochloride

Tablet, 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:
68788-7786-6
Package Description:
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Bupropion Hydrochloride
Non-Proprietary Name:
Bupropion Hydrochloride
Substance Name:
Bupropion Hydrochloride
Usage Information:
•Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder. •Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride extended-release tablets (XL) [see Warnings and Precautions (5.3)]. •Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3) and Drug Interactions (7.3)]. •The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride extended-release tablets (XL) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets (XL) is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrochloride extended-release tablets (XL) are used concomitantly with MAOIs. The use of bupropion hydrochloride extended-release tablets (XL) within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting bupropion hydrochloride extended-release tablets (XL) in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration (2.9), Warnings and Precautions (5.4) and Drug Interactions (7.6)]. •Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (XL). Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been reported [see Warnings and Precautions (5.8)].
11-Digit NDC Billing Format:
68788778606
Product Type:
Human Prescription Drug
Labeler Name:
Preferred Pharmaceuticals Inc.
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA210497
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-21-2020
    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
    68788-7786-1100 TABLET, EXTENDED RELEASE in 1 BOTTLE
    68788-7786-330 TABLET, EXTENDED RELEASE in 1 BOTTLE
    68788-7786-8120 TABLET, EXTENDED RELEASE in 1 BOTTLE
    68788-7786-990 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68788-7786-6?

    The NDC Packaged Code 68788-7786-6 is assigned to a package of 60 tablet, extended release in 1 bottle of Bupropion Hydrochloride, a human prescription drug labeled by Preferred Pharmaceuticals Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 68788-7786 included in the NDC Directory?

    Yes, Bupropion Hydrochloride with product code 68788-7786 is active and included in the NDC Directory. The product was first marketed by Preferred Pharmaceuticals Inc. on October 21, 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 68788-7786-6?

    The 11-digit format is 68788778606. 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
    5-4-168788-7786-65-4-268788-7786-06