Diethylpropion Hydrochloride Tablet
NDC Package 84053-044-21

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Diethylpropion Hydrochloride tablets is diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. This formulation utilizes a tablet delivery system. Marketed by Martek Pharmacal Co., this product is identified by NDC 84053-044 and is authorized under FDA application ANDA201212.

Identification & Billing

NDC Package Code
84053-044-21
Package Description
21 TABLET in 1 BOTTLE
Product Code
84053-044
11-Digit Billing Format
84053004421
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diethylpropion Hydrochloride
Non-Proprietary Name
Diethylpropion Hydrochloride
Substance Name
Diethylpropion Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIETHYLPROPION HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters. Body Mass Index (BMI), kg/m 2Weight (pounds)Height (feet, inches)5’0”5’3”5’6”5’9”6’0”6’3”140272523211918150292724222019160312826242220170333028252321180353229272523190373431282624200393632302725210413734312926220433936333028230454137343129240474339363330250494440373431The usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride is indicated for use as monotherapy only.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Martek Pharmacal Co.
Product Type
Human Prescription Drug
FDA Application #
ANDA201212
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-05-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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 84053-044-21 identifies a specific commercial package of 21 tablet in 1 bottle of Diethylpropion Hydrochloride, a human prescription drug labeled by Martek Pharmacal Co.. This tablet is formulated for oral use and contains diethylpropion hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Martek Pharmacal Co. on March 05, 2024. The current certification is valid through December 31, 2026.

How is this Martek Pharmacal Co. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84053004421. 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)
84053-044-21
11-Digit CMS (5-4-2)
84053-0044-21

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