Toiramate
NDC Package 53104-0121-9

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.

Toiramate is a . Marketed by Cipla Limited, this product is identified by NDC 53104-0121 and is authorized under FDA application ANDA076343.

Identification & Billing

NDC Package Code
53104-0121-9
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
53104-0121
11-Digit Billing Format
53104012109

Clinical Specifications

Proprietary Name
Toiramate
Dosage Form
-

Regulatory & Marketing

Labeler Name
Cipla Limited
FDA Application #
ANDA076343
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-27-2009
End Marketing Date
06-12-2014
Listing Expiration
06-12-2014
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 (53104-0121). Click a package code to view its specific billing and regulatory data.

53104-0121-4
100 TABLET in 1 BOTTLE
53104-0121-8
4000 TABLET 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 53104-0121-9 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet in 1 blister pack of Toiramate, labeled by Cipla Limited. 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 Cipla Limited on March 27, 2009. The current certification is valid through June 12, 2014.

How is this Cipla Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53104012109. 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 (5-4-1)
53104-0121-9
11-Digit CMS (5-4-2)
53104-0121-09

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