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  5. NDC Package Code: 71335-0548-0 Topiramate

NDC Package 71335-0548-0 Topiramate

Tablet, Film Coated 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:
71335-0548-0
Package Description:
28 TABLET, FILM COATED in 1 BOTTLE
Product Code:
71335-0548
Proprietary Name:
Topiramate
Non-Proprietary Name:
Topiramate
Substance Name:
Topiramate
Usage Information:
Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). This medication is also used to prevent migraine headaches and decrease how often you get them. Topiramate will not treat a migraine headache once it occurs. If you get a migraine headache, treat it as directed by your doctor (such as by taking pain medication, lying down in a dark room). Topiramate is known as an anticonvulsant or antiepileptic drug.
11-Digit NDC Billing Format:
71335054800
NDC to RxNorm Crosswalk:
  • RxCUI: 199888 - topiramate 25 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • TOPIRAMATE 25 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA090278
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-15-2014
    Listing Expiration Date:
    12-31-2024
    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
    71335-0548-130 TABLET, FILM COATED in 1 BOTTLE
    71335-0548-260 TABLET, FILM COATED in 1 BOTTLE
    71335-0548-390 TABLET, FILM COATED in 1 BOTTLE
    71335-0548-456 TABLET, FILM COATED in 1 BOTTLE
    71335-0548-584 TABLET, FILM COATED in 1 BOTTLE
    71335-0548-6120 TABLET, FILM COATED in 1 BOTTLE
    71335-0548-77 TABLET, FILM COATED in 1 BOTTLE
    71335-0548-814 TABLET, FILM COATED in 1 BOTTLE
    71335-0548-945 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71335-0548-0?

    The NDC Packaged Code 71335-0548-0 is assigned to a package of 28 tablet, film coated in 1 bottle of Topiramate, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 71335-0548 included in the NDC Directory?

    Yes, Topiramate with product code 71335-0548 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on December 15, 2014 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71335-0548-0?

    The 11-digit format is 71335054800. 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 5-4-1 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
    5-4-171335-0548-05-4-271335-0548-00