Equetro
NDC Package 54092-421-12

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.

Equetro is carbamazepine is used to prevent and control seizures. Marketed by Shire Us Manufacturing Inc., this product is identified by NDC 54092-421 and is authorized under FDA application NDA021710.

Identification & Billing

NDC Package Code
54092-421-12
Package Description
120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
54092-421
11-Digit Billing Format
54092042112

Clinical Specifications

Proprietary Name
Equetro
Dosage Form
-
Usage Information
Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia). This medication works by reducing the spread of seizure activity in the brain and restoring the normal balance of nerve activity. Some forms of this medication are also used to treat bipolar disorder. Carbamazepine can help to decrease extreme changes in mood and help you feel less agitated.

Regulatory & Marketing

Labeler Name
Shire Us Manufacturing Inc.
FDA Application #
NDA021710
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-10-2004
End Marketing Date
04-30-2009
Listing Expiration
04-30-2009
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 54092-421-12 identifies a specific commercial package of 120 capsule, extended release in 1 bottle of Equetro, labeled by Shire Us Manufacturing 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 Shire Us Manufacturing Inc. on December 10, 2004. The current certification is valid through April 30, 2009.

What are the primary indications for this medication?

Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia). This medication works by reducing the spread of seizure activity in the brain and restoring the normal balance of nerve activity. Some forms of this medication are also used to treat bipolar disorder. Carbamazepine can help to decrease extreme changes in mood and help you feel less agitated.

How is this Shire Us Manufacturing Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54092042112. 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)
54092-421-12
11-Digit CMS (5-4-2)
54092-0421-12

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