Phentermine And Topiramate Capsule, Extended Release
NDC Package 0480-3296-99

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 And Topiramate capsules is phentermine and topiramate extended-release capsules are indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:Adults with an initial body mass index (BMI) of:30 kg/m2 or greater (obese), or27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemiaLimitations of UseThe effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established.The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.Pediatric use information is approved for Vivus LLC's Qsymia® (phentermine and topiramate) extended-release capsules. This formulation utilizes a capsule, extended release delivery system. Marketed by Teva Pharmaceuticals, Inc., this product is identified by NDC 0480-3296 and is authorized under FDA application ANDA204982.

Identification & Billing

NDC Package Code
0480-3296-99
Package Description
14719 CAPSULE, EXTENDED RELEASE in 1 CONTAINER
Product Code
0480-3296
11-Digit Billing Format
00480329699
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: 1302839 - phentermine 3.75 MG / topiramate 23 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1302839 - 24 HR phentermine 3.75 MG / topiramate 23 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Phentermine And Topiramate
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
Phentermine and topiramate extended-release capsules are indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:Adults with an initial body mass index (BMI) of:30 kg/m2 or greater (obese), or27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemiaLimitations of UseThe effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established.The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.Pediatric use information is approved for Vivus LLC's Qsymia® (phentermine and topiramate) extended-release capsules. However, due to Vivus LLC's marketing exclusivity rights, this drug product is not labeled with that information.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204982
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-07-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
N/A

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 (0480-3296). Click a package code to view its specific billing and regulatory data.

0480-3296-56
30 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 0480-3296-99 identifies a specific commercial package of 14719 capsule, extended release in 1 container of Phentermine And Topiramate, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. 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 Teva Pharmaceuticals, Inc. on May 07, 2025. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00480329699. 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 (4-4-2)
0480-3296-99
11-Digit CMS (5-4-2)
00480-3296-99

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