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  5. NDC Package Code: 0480-3295-56 Phentermine And Topiramate

NDC Package 0480-3295-56 Phentermine And Topiramate

Capsule, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0480-3295-56
Package Description:
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0480-3295
Proprietary Name:
Phentermine And Topiramate
Non-Proprietary Name:
Phentermine And Topiramate
Substance Name:
Phentermine Hydrochloride; Topiramate
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.
11-Digit NDC Billing Format:
00480329556
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
Product Type:
Human Prescription Drug
Labeler Name:
Teva Pharmaceuticals, Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
DEA Schedule:
Schedule IV (CIV) Substances
Sample Package:
No
FDA Application Number:
ANDA204982
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-07-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0480-3295-997805 CAPSULE, EXTENDED RELEASE in 1 CONTAINER

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0480-3295-56?

The NDC Packaged Code 0480-3295-56 is assigned to a package of 30 capsule, extended release in 1 bottle of Phentermine And Topiramate, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. The product's dosage form is capsule, extended release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

Is NDC 0480-3295 included in the NDC Directory?

Yes, Phentermine And Topiramate with product code 0480-3295 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals, Inc. on May 07, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0480-3295-56?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 0480-3295-56?

The 11-digit format is 00480329556. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20480-3295-565-4-200480-3295-56