phentermine and topiramate (0480-3296)

Drug Facts

Product Profile

Brand Name phentermine and topiramate

Generic Name phentermine and topiramate

Labeler teva pharmaceuticals, inc.

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

phentermine hydrochloride 7.5 mg/1, topiramate 46 mg/1

Manufacturer

Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3296

Product ID 0480-3296_658f69a4-7121-43a9-8933-22a082740593

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204982

DEA Schedule civ

Listing Expiration 2027-12-31

Marketing Start 2025-05-07

Pharmacologic Class

Mechanism of Action

cytochrome p450 3a4 inducers [moa] cytochrome p450 2c19 inhibitors [moa]

Physiologic Effect

decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803296

Hyphenated Format 0480-3296

Supplemental Identifiers

RxCUI

1302827 1302839 1302850 1313059

UNII

0K2I505OTV 0H73WJJ391

NUI

N0000008486 N0000185506 N0000182140

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name phentermine and topiramate (source: ndc)

Generic Name phentermine and topiramate (source: ndc)

Application Number ANDA204982 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

7.5 mg/1
46 mg/1

source: ndc

Packaging

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3296-56)

source: ndc

Packages (1)

0480-3296-56 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3296-56)

Ingredients (2)

phentermine hydrochloride (7.5 mg/1) topiramate (46 mg/1)

Linked Drug Pages (1)

Phentermine and topiramate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

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