Appbutamone
NDC Package 68405-021-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Appbutamone is iNDICATIONS AND USAGEBupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. Marketed by Physician Therapeutics Llc, this product is identified by NDC 68405-021.

Identification & Billing

NDC Package Code
68405-021-16
Package Description
1 KIT in 1 KIT * 120 CAPSULE in 1 BOTTLE * 30 TABLET in 1 BOTTLE (52959-898-30)
Product Code
68405-021
11-Digit Billing Format
68405002116
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Appbutamone
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Physician Therapeutics Llc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
07-07-2011
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68405-021-16 identifies a specific commercial package of 1 kit in 1 kit * 120 capsule in 1 bottle * 30 tablet in 1 bottle (52959-898-30) of Appbutamone, labeled by Physician Therapeutics Llc. 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 Physician Therapeutics Llc on July 07, 2011. The current certification is valid through December 31, 2017.

How is this Physician Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68405002116. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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:

10-Digit Format (5-3-2)
68405-021-16
11-Digit CMS (5-4-2)
68405-0021-16

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.