Bupropion Hydrochloride
NDC Package 68258-7157-9
Package Information
Bupropion Hydrochloride is extended-release tablets (SR) 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 depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY).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 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 PHARMACOLOGY). Marketed by Dispensing Solutions, Inc., this product is identified by NDC 68258-7157 and is authorized under FDA application ANDA078866.
Identification & Billing
- RxCUI: 993503 - buPROPion HCl 100 MG 12HR Extended Release Oral Tablet
- RxCUI: 993503 - 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet
- RxCUI: 993503 - bupropion HCl 100 MG 12 HR Extended Release Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 68258 - Dispensing Solutions, Inc.
- 68258-7157 - Bupropion Hydrochloride
- 68258-7157-9 - 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
- 68258-7157 - Bupropion Hydrochloride
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (68258-7157). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 68258-7157-9 identifies a specific commercial package of 90 tablet, film coated, extended release in 1 bottle, plastic of Bupropion Hydrochloride, labeled by Dispensing Solutions, Inc.. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Dispensing Solutions, Inc. on April 08, 2010. The current certification is valid through December 31, 2017.
How is this Dispensing Solutions, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258715709. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
