NDC Package 16590-589-30 Budeprion XL

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Package Information
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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:

16590-589-30

Package Description:

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Product Code:

16590-589

Proprietary Name:

Budeprion XL

Usage Information:

INDICATIONS AND USAGEMajor 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.

11-Digit NDC Billing Format:

16590058930

Labeler Name:

Stat Rx Usa Llc

Sample Package:

Start Marketing Date:

12-14-2006

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

16590 - Stat Rx Usa Llc
- 16590-589 - Budeprion
  - 16590-589-30 - 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

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 Code	Package Description
16590-589-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
16590-589-90	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 16590-589-30?

The NDC Packaged Code 16590-589-30 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle of Budeprion XL, labeled by Stat Rx Usa Llc. The product's dosage form is and is administered via form.

Is NDC 16590-589 included in the NDC Directory?

No, Budeprion XL with product code 16590-589 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Stat Rx Usa Llc on December 14, 2006 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 11-digit format for NDC 16590-589-30?

The 11-digit format is 16590058930. 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	16590-589-30	5-4-2	16590-0589-30

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