Phentermine Hydrochloride Tablet
NDC Package 43063-596-30

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 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/m 2, or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). This formulation utilizes a tablet delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 43063-596 and is authorized under FDA application ANDA040526.

Identification & Billing

NDC Package Code
43063-596-30
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
43063-596
11-Digit Billing Format
43063059630
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

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 30 mg/1
Pharmacologic Class
Usage Information
Phentermine hydrochloride 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/m 2, or ≥ 27 kg/m 2 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/m 2The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [ 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
Pd-rx Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040526
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-12-2013
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 (43063-596). Click a package code to view its specific billing and regulatory data.

43063-596-01
100 TABLET in 1 BOTTLE, PLASTIC
43063-596-07
7 TABLET in 1 BOTTLE, PLASTIC
43063-596-14
14 TABLET in 1 BOTTLE, PLASTIC
43063-596-15
15 TABLET in 1 BOTTLE, PLASTIC
43063-596-21
21 TABLET in 1 BOTTLE, PLASTIC
43063-596-28
28 TABLET in 1 BOTTLE, PLASTIC
43063-596-32
32 TABLET in 1 BOTTLE, PLASTIC
43063-596-42
42 TABLET in 1 BOTTLE, PLASTIC
43063-596-45
45 TABLET in 1 BOTTLE, PLASTIC
43063-596-60
60 TABLET in 1 BOTTLE, PLASTIC
43063-596-90
90 TABLET in 1 BOTTLE, PLASTIC
43063-596-93
180 TABLET in 1 BOTTLE, PLASTIC

* 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 43063-596-30 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Phentermine Hydrochloride, a human prescription drug labeled by Pd-rx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Pd-rx Pharmaceuticals, Inc. on August 12, 2013. The current certification is valid through December 31, 2026.

How is this Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43063059630. 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)
43063-596-30
11-Digit CMS (5-4-2)
43063-0596-30

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