Topiramate Tablet, Film Coated
NDC Package 47335-710-83

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

Topiramate tablets is topiramate is used alone or with other medications to prevent and control seizures (epilepsy). This formulation utilizes a tablet, film coated delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-710 and is authorized under FDA application ANDA090278.

Identification & Billing

NDC Package Code
47335-710-83
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
47335-710
11-Digit Billing Format
47335071083

Clinical Specifications

Proprietary Name
Topiramate
Non-Proprietary Name
Topiramate
Substance Name
Topiramate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TOPIRAMATE 50 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090278
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2014
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 (47335-710). Click a package code to view its specific billing and regulatory data.

47335-710-08
100 TABLET, FILM COATED in 1 BOTTLE
47335-710-13
500 TABLET, FILM COATED in 1 BOTTLE
47335-710-18
1000 TABLET, FILM COATED in 1 BOTTLE
47335-710-86
60 TABLET, FILM COATED in 1 BOTTLE
47335-710-88
100 TABLET, FILM COATED 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 47335-710-83 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Topiramate, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet, film coated is formulated for oral use and contains 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 Sun Pharmaceutical Industries, Inc. on December 15, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335071083. 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)
47335-710-83
11-Digit CMS (5-4-2)
47335-0710-83

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