Phentermine Hydrochloride
NDC Package 54868-6290-0

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.

Phentermine Hydrochloride is capsules 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 Physicians Total Care, Inc., this product is identified by NDC 54868-6290 and is authorized under FDA application ANDA201961.

Identification & Billing

NDC Package Code
54868-6290-0
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
54868-6290
11-Digit Billing Format
54868629000
RxNorm Crosswalk
  • RxCUI: 803348 - phentermine HCl 37.5 MG Oral Capsule
  • RxCUI: 803348 - phentermine hydrochloride 37.5 MG Oral Capsule
  • RxCUI: 803348 - phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Capsule

Clinical Specifications

Proprietary Name
Phentermine Hydrochloride
Dosage Form
-
Usage Information
Phentermine hydrochloride capsules 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 x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2 Height (feet, inches)Weight(pounds)5'0"5'3"5'6"5'9"6'0"6'3" 1402725232119 18 15029 27 24 22 2019 1603128262422 20 17033 30 28 25 2321 18035322927 2523 190373431 28 26 24 2003936323027 25 21041373431 29 26 2204339363330 28 230454137 343129 240 47 43 39 36 3330 250494440 373431The 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
Physicians Total Care, Inc.
FDA Application #
ANDA201961
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-29-2011
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 54868-6290-0 identifies a specific commercial package of 30 capsule in 1 bottle of Phentermine Hydrochloride, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on July 29, 2011. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868629000. 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)
54868-6290-0
11-Digit CMS (5-4-2)
54868-6290-00

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