Qsymia Capsule, Extended Release
NDC Package 62541-201-14

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

Qsymia (phentermine and topiramate) capsules is a medication 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 Vivus Llc, this product is identified by NDC 62541-201 and is authorized under FDA application NDA022580.

Identification & Billing

NDC Package Code
62541-201-14
Package Description
14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE
Product Code
62541-201
11-Digit Billing Format
62541020114
RxNorm Crosswalk
  • RxCUI: 1302827 - phentermine 7.5 MG / topiramate 46 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1302827 - 24 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral Capsule
  • RxCUI: 1302827 - phentermine 7.5 MG / topiramate 46 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 1302833 - Qsymia 7.5 MG / 46 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1302833 - 24 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral Capsule [Qsymia]

Clinical Specifications

Proprietary Name
Qsymia
Non-Proprietary Name
Phentermine And Topiramate
Substance Name
Phentermine Hydrochloride; Topiramate
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)
Pharmacologic Class
Usage Information
This medication 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, by increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is a combination of phentermine and topiramate. Phentermine is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines. Topiramate is known as an anticonvulsant or antiepileptic drug.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Vivus Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022580
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-17-2012
Listing Expiration
12-31-2027
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 (62541-201). Click a package code to view its specific billing and regulatory data.

62541-201-30
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE

* 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 62541-201-14 identifies a specific commercial package of 14 capsule, extended release in 1 bottle, unit-dose of Qsymia, a human prescription drug labeled by Vivus Llc. This capsule, extended release is formulated for oral use and contains phentermine hydrochloride; topiramate 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 Vivus Llc on September 17, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication 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, by increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is a combination of phentermine and topiramate. Phentermine is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines. Topiramate is known as an anticonvulsant or antiepileptic drug.

How is this Vivus Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62541020114. 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)
62541-201-14
11-Digit CMS (5-4-2)
62541-0201-14

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