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  5. NDC Package Code: 71335-1542-1 Bupropion Hydrochloride (xl)

NDC Package 71335-1542-1 Bupropion Hydrochloride (xl)

Bupropion Hydrochloride Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
71335-1542-1
Package Description:
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
71335-1542
Proprietary Name:
Bupropion Hydrochloride (xl)
Non-Proprietary Name:
Bupropion Hydrochloride
Substance Name:
Bupropion Hydrochloride
Usage Information:
Bupropion 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 [seeClinical Studies(14.1)].
11-Digit NDC Billing Format:
71335154201
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
  • RxCUI: 993557 - buPROPion HCl 300 MG 24HR Extended Release Oral Tablet
  • RxCUI: 993557 - 24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    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):
  • BUPROPION HYDROCHLORIDE 150 mg/1
    • Pharmacologic Class(es):
  • Aminoketone - [EPC] (Established Pharmacologic Class)
  • Dopamine Uptake Inhibitors - [MoA] (Mechanism of Action)
  • Increased Dopamine Activity - [PE] (Physiologic Effect)
  • Increased Norepinephrine Activity - [PE] (Physiologic Effect)
  • Norepinephrine Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA208652
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-08-2018
    Listing Expiration Date:
    12-31-2024
    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
    71335-1542-260 TABLET, EXTENDED RELEASE in 1 BOTTLE
    71335-1542-390 TABLET, EXTENDED RELEASE in 1 BOTTLE
    71335-1542-4120 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71335-1542-1?

    The NDC Packaged Code 71335-1542-1 is assigned to a package of 30 tablet, extended release in 1 bottle of Bupropion Hydrochloride (xl), a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 71335-1542 included in the NDC Directory?

    Yes, Bupropion Hydrochloride (xl) with product code 71335-1542 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on January 08, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71335-1542-1?

    The 11-digit format is 71335154201. 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
    5-4-171335-1542-15-4-271335-1542-01