Phendimetrazine Tartrate Capsule, Extended Release
NDC Package 72989-409-30

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

Phendimetrazine Tartrate capsules is phendimetrazine is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. This formulation utilizes a capsule, extended release delivery system. Marketed by Acertis Pharmaceuticals, Llc, this product is identified by NDC 72989-409 and is authorized under FDA application NDA018074.

Identification & Billing

NDC Package Code
72989-409-30
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
72989-409
11-Digit Billing Format
72989040930
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: 979543 - phendimetrazine tartrate 105 MG 24HR Extended Release Oral Capsule
  • RxCUI: 979543 - 24 HR phendimetrazine tartrate 105 MG Extended Release Oral Capsule
  • RxCUI: 979543 - phendimetrazine 105 MG 24 HR Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Phendimetrazine Tartrate
Non-Proprietary Name
Phendimetrazine Tartrate
Substance Name
Phendimetrazine Tartrate
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PHENDIMETRAZINE TARTRATE 105 mg/1
Pharmacologic Class
Usage Information
Phendimetrazine is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Acertis Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA018074
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2022
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 (72989-409). Click a package code to view its specific billing and regulatory data.

72989-409-11
1000 CAPSULE, EXTENDED RELEASE 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 72989-409-30 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Phendimetrazine Tartrate, a human prescription drug labeled by Acertis Pharmaceuticals, Llc. This capsule, extended release is formulated for oral use and contains phendimetrazine tartrate 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 Acertis Pharmaceuticals, Llc on November 01, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Phendimetrazine is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines.

How is this Acertis Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72989040930. 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)
72989-409-30
11-Digit CMS (5-4-2)
72989-0409-30

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