Diethylpropion Hydrochloride Er Tablet, Extended Release
NDC Package 62135-489-30

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

Package Information

Diethylpropion Hydrochloride Er (diethylpropion hydrochloride) tablets is diethylpropion hydrochloride extended release tablets, 75 mg are 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, extended release delivery system. Marketed by Chartwell Rx, Llc., this product is identified by NDC 62135-489 and is authorized under FDA application ANDA091680.

Identification & Billing

NDC Package Code
62135-489-30
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
62135-489
11-Digit Billing Format
62135048930
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 978668 - diethylpropion HCl 75 MG 24HR Extended Release Oral Tablet
  • RxCUI: 978668 - 24 HR diethylpropion hydrochloride 75 MG Extended Release Oral Tablet
  • RxCUI: 978668 - diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Diethylpropion Hydrochloride Er
Non-Proprietary Name
Diethylpropion Hydrochloride
Substance Name
Diethylpropion Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIETHYLPROPION HYDROCHLORIDE 75 mg/1
Pharmacologic Class
Usage Information
Diethylpropion hydrochloride extended release tablets, 75 mg are 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 extended release tablets, 75 mg are indicated for use as monotherapy only.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Chartwell Rx, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA091680
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-24-2011
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 62135-489-30 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Diethylpropion Hydrochloride Er, a human prescription drug labeled by Chartwell Rx, Llc.. This tablet, extended release 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 Chartwell Rx, Llc. on October 24, 2011. The current certification is valid through December 31, 2026.

How is this Chartwell Rx, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135048930. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
62135-489-30
11-Digit CMS (5-4-2)
62135-0489-30

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