Topamax
NDC Package 0045-0639-65

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Topamax is topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Marketed by Mcneil Pharmaceuticals, this product is identified by NDC 0045-0639 and is authorized under FDA application NDA020505.

Identification & Billing

NDC Package Code
0045-0639-65
Package Description
60 TABLET, COATED in 1 BOTTLE
Product Code
0045-0639
11-Digit Billing Format
00045063965

Clinical Specifications

Proprietary Name
Topamax
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
Mcneil Pharmaceuticals
FDA Application #
NDA020505
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-1997
End Marketing Date
07-31-2010
Listing Expiration
07-31-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0045-0639-65 identifies a specific commercial package of 60 tablet, coated in 1 bottle of Topamax, labeled by Mcneil Pharmaceuticals. 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 Mcneil Pharmaceuticals on January 01, 1997. The current certification is valid through July 31, 2010.

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 Mcneil Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00045063965. 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 (4-4-2)
0045-0639-65
11-Digit CMS (5-4-2)
00045-0639-65

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