Phentermine Hydrochloride Tablet
NDC Package 52605-022-01

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

Phentermine Hydrochloride tablets is phentermine hydrochloride tablets, USP  is 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 patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. This formulation utilizes a tablet delivery system. Marketed by Polygen Pharmaceuticals Inc., this product is identified by NDC 52605-022 and is authorized under FDA application ANDA206342.

Identification & Billing

NDC Package Code
52605-022-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
52605-022
11-Digit Billing Format
52605002201
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
Non-Proprietary Name
Phentermine Hydrochloride
Substance Name
Phentermine 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)
PHENTERMINE HYDROCHLORIDE 37.5 mg/1
Pharmacologic Class
Usage Information
Phentermine hydrochloride tablets, USP  is 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 patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.The limited usefulness of agents of this class, including  Phentermine hydrochloride tablets, USP [see Clinical Pharmacology (12.1, 12.2)] should be measured against  possible risk factors inherent in their use such as those described below.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Polygen Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206342
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-18-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52605-022). Click a package code to view its specific billing and regulatory data.

52605-022-10
1000 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 52605-022-01 identifies a specific commercial package of 100 tablet in 1 bottle of Phentermine Hydrochloride, a human prescription drug labeled by Polygen Pharmaceuticals Inc.. This tablet is formulated for oral use and contains phentermine 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 Polygen Pharmaceuticals Inc. on November 18, 2016. The current certification is valid through December 31, 2026.

How is this Polygen Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52605002201. 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)
52605-022-01
11-Digit CMS (5-4-2)
52605-0022-01

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