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  5. NDC Package Code: 53808-0347-1 Bupropion Hydrochloride

NDC Package 53808-0347-1 Bupropion Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
53808-0347-1
Package Description:
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
53808-0347
Proprietary Name:
Bupropion Hydrochloride
Usage Information:
Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. A physician considering bupropion for the management of a patient’s first episode of depression should be aware that the drug may cause generalized seizures in a dose dependent manner with an approximate incidence of 0.4% (4/1,000). This incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted (see WARNINGS).The efficacy of bupropion has been established in three placebo-controlled trials, including two of approximately 3 weeks’ duration in depressed inpatients and one of approximately 6 weeks’ duration in depressed outpatients. The depressive disorder of the patients studied corresponds most closely to the Major Depression category of the APA Diagnostic and Statistical Manual III.Major depression implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.Effectiveness of bupropion in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use bupropion for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
11-Digit NDC Billing Format:
53808034701
NDC to RxNorm Crosswalk:
  • RxCUI: 993687 - buPROPion HCl 100 MG Oral Tablet
  • RxCUI: 993687 - bupropion hydrochloride 100 MG Oral Tablet
  • RxCUI: 993691 - buPROPion HCl 75 MG Oral Tablet
  • RxCUI: 993691 - bupropion hydrochloride 75 MG Oral Tablet
  • RxCUI: 993691 - bupropion HCl 75 MG Oral Tablet
    • Labeler Name:
    State Of Florida Doh Central Pharmacy
    Sample Package:
    No
    Start Marketing Date:
    07-01-2009
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    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 53808-0347-1?

    The NDC Packaged Code 53808-0347-1 is assigned to a package of 30 tablet, film coated in 1 blister pack of Bupropion Hydrochloride, labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is and is administered via form.

    Is NDC 53808-0347 included in the NDC Directory?

    No, Bupropion Hydrochloride with product code 53808-0347 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by State Of Florida Doh Central Pharmacy on July 01, 2009 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 53808-0347-1?

    The 11-digit format is 53808034701. 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
    5-4-153808-0347-15-4-253808-0347-01