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  5. NDC Package Code: 61919-558-72 Bupropion Hcl Er (xl)

NDC Package 61919-558-72 Bupropion Hcl Er (xl)

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

Table of Contents

    1. Package Information
    2. 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:
61919-558-72
Package Description:
120 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
61919-558
Proprietary Name:
Bupropion Hcl Er (xl)
Non-Proprietary Name:
Bupropion Hcl Er (xl)
Substance Name:
Bupropion Hydrochloride
Usage Information:
1.1 Major Depressive Disorder (MDD)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 [see CLINICAL STUDIES (14.1)].1.2 Seasonal Affective Disorder (SAD)Bupropion 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:
61919055872
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
120 EA
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Direct_rx
    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:
    ANDA090693
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-15-2024
    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.

    Frequently Asked Questions

    What is NDC 61919-558-72?

    The NDC Packaged Code 61919-558-72 is assigned to a package of 120 tablet, extended release in 1 bottle of Bupropion Hcl Er (xl), a human prescription drug labeled by Direct_rx. The product's dosage form is tablet, extended release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package.

    Is NDC 61919-558 included in the NDC Directory?

    Yes, Bupropion Hcl Er (xl) with product code 61919-558 is active and included in the NDC Directory. The product was first marketed by Direct_rx on February 15, 2024 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 NDC billing unit for package 61919-558-72?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 120.

    What is the 11-digit format for NDC 61919-558-72?

    The 11-digit format is 61919055872. 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 5-3-2 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
    5-3-261919-558-725-4-261919-0558-72