Topiramate
NDC Package 33261-400-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Topiramate is used alone or with other medications to prevent and control seizures (epilepsy). Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-400 and is authorized under FDA application ANDA079162.

Identification & Billing

NDC Package Code
33261-400-07
Package Description
7 TABLET in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
33261040007
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
7 EA
RxNorm Crosswalk

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
Aidarex Pharmaceuticals Llc
FDA Application #
ANDA079162
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2011
Listing Expiration
12-31-2018
Exclude Flag
I
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 (33261-400). Click a package code to view its specific billing and regulatory data.

120 TABLET in 1 BOTTLE, PLASTIC
14 TABLET in 1 BOTTLE, PLASTIC
28 TABLET in 1 BOTTLE, PLASTIC
30 TABLET in 1 BOTTLE, PLASTIC
60 TABLET in 1 BOTTLE, PLASTIC
90 TABLET in 1 BOTTLE, PLASTIC

* 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 33261-400-07 identifies a specific commercial package of 7 tablet in 1 bottle, plastic of Topiramate, labeled by Aidarex Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 7 billable units per package. 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 Aidarex Pharmaceuticals Llc on January 01, 2011. The current certification is valid through December 31, 2018.

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 Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261040007. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 7 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)
33261-400-07
11-Digit CMS (5-4-2)
33261-0400-07

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