Topiramate
NDC Package 16571-708-06

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 16571-708 and is authorized under FDA application ANDA078462.

Identification & Billing

NDC Package Code
16571-708-06
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
16571-708
11-Digit Billing Format
16571070806
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

Clinical Specifications

Proprietary Name
Topiramate
Dosage Form
-
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
Rising Pharma Holdings, Inc.
FDA Application #
ANDA078462
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-27-2009
End Marketing Date
05-31-2024
Listing Expiration
05-31-2024
Exclude Flag
D
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 (16571-708). Click a package code to view its specific billing and regulatory data.

16571-708-10
1000 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 16571-708-06 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Topiramate, labeled by Rising Pharma Holdings, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rising Pharma Holdings, Inc. on March 27, 2009. The current certification is valid through May 31, 2024.

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 Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16571070806. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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)
16571-708-06
11-Digit CMS (5-4-2)
16571-0708-06

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