NDC Package 21695-578-30 Bupropion Hydrochloride XL

View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

21695-578-30

Package Description:

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Code:

21695-578

Proprietary Name:

Bupropion Hydrochloride XL

Usage Information:

Major Depressive Disorder: Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder.The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS).A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (XL) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.Seasonal Affective Disorder: 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.The efficacy of bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (see CLINICAL TRIALS).Seasonal affective disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and/or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the number of non-seasonal episodes during the individual's lifetime.

11-Digit NDC Billing Format:

21695057830

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 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

RxCUI: 993557 - buPROPion HCl 300 MG 24HR Extended Release Oral Tablet

RxCUI: 993557 - 24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet

Labeler Name:

Rebel Distributors Corp

Sample Package:

Start Marketing Date:

06-13-2007

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

21695 - Rebel Distributors Corp
- 21695-578 - Bupropion Hydrochloride
  - 21695-578-30 - 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

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 21695-578-30?

The NDC Packaged Code 21695-578-30 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle, plastic of Bupropion Hydrochloride XL, labeled by Rebel Distributors Corp. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

Is NDC 21695-578 included in the NDC Directory?

No, Bupropion Hydrochloride XL with product code 21695-578 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rebel Distributors Corp on June 13, 2007 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 21695-578-30?

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 30.

What is the 11-digit format for NDC 21695-578-30?

The 11-digit format is 21695057830. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	21695-578-30	5-4-2	21695-0578-30

Table of Contents