Phentermine Hydrochloride
NDC Package 50436-0101-2

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Phentermine Hydrochloride is tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).Below is a chart of body mass index (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. Marketed by Unit Dose Services, this product is identified by NDC 50436-0101 and is authorized under FDA application ANDA200272.

Identification & Billing

NDC Package Code
50436-0101-2
Package Description
14 TABLET in 1 BOTTLE
Product Code
50436-0101
11-Digit Billing Format
50436010102
RxNorm Crosswalk
  • RxCUI: 803353 - phentermine HCl 37.5 MG Oral Tablet
  • RxCUI: 803353 - phentermine hydrochloride 37.5 MG Oral Tablet
  • RxCUI: 803353 - phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Phentermine Hydrochloride
Dosage Form
-
Usage Information
Phentermine hydrochloride Tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).Below is a chart of body mass index (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 ÷ 2.2 = kg; inches × 0.0254 = meters.BODY MASS INDEX (BMI), kg/m2Weight (pounds)Height (feet, inches)5'0"5'3"5'6"5'9"6'0"6'3"140272523211918150292724222019160312826242220170333028252321180353229272523190373431282624200393632302725210413734312926220433936333028230454137343129The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA200272
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-08-2011
Listing Expiration
12-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50436-0101). Click a package code to view its specific billing and regulatory data.

50436-0101-1
7 TABLET in 1 BOTTLE
50436-0101-3
21 TABLET in 1 BOTTLE
50436-0101-4
28 TABLET in 1 BOTTLE

* 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 50436-0101-2 identifies a specific commercial package of 14 tablet in 1 bottle of Phentermine Hydrochloride, labeled by Unit Dose Services. 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 Unit Dose Services on March 08, 2011. The current certification is valid through December 31, 2022.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436010102. 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 (5-4-1)
50436-0101-2
11-Digit CMS (5-4-2)
50436-0101-02

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