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  5. NDC Package Code: 68405-009-16 Appbutamone-d

NDC Package 68405-009-16 Appbutamone-d

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:
68405-009-16
Package Description:
1 KIT in 1 KIT * 120 CAPSULE in 1 BOTTLE * 30 TABLET in 1 BOTTLE (52959-898-30)
Product Code:
68405-009
Proprietary Name:
Appbutamone-d
Usage Information:
INDICATIONS AND USAGEBupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. A physician considering bupropion hydrochloride tablets 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 hydrochloride tablets has been established in 3 placebo-controlled trials, including 2 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 4 of the following 8 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 hydrochloride tablets 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 hydrochloride tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. INDICATIONS FOR USE AppTrim is intended for the clinical nutritional management of the metabolic processes in patients with obesity, morbid obesity, and metabolic syndrome. • To control appetite and carbohydrate cravings in obese patients who are undergoing a medically supervised weight loss program. • To control appetite and carbohydrate cravings in patients who are being treated for metabolic syndrome. • To control appetite and carbohydrate cravings in patients preparing for bariatric surgery. • To control appetite and carbohydrate cravings in patients following bariatric surgery.
11-Digit NDC Billing Format:
68405000916
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • 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:
    Physician Therapeutics Llc
    Sample Package:
    No
    Start Marketing Date:
    07-07-2011
    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 68405-009-16?

    The NDC Packaged Code 68405-009-16 is assigned to a package of 1 kit in 1 kit * 120 capsule in 1 bottle * 30 tablet in 1 bottle (52959-898-30) of Appbutamone-d, labeled by Physician Therapeutics Llc. The product's dosage form is and is administered via form.

    Is NDC 68405-009 included in the NDC Directory?

    No, Appbutamone-d with product code 68405-009 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Physician Therapeutics Llc on July 07, 2011 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 68405-009-16?

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

    What is the 11-digit format for NDC 68405-009-16?

    The 11-digit format is 68405000916. 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
    5-3-268405-009-165-4-268405-0009-16