Carbamazepine
NDC Package 69189-4124-1

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.

Carbamazepine is used to prevent and control seizures. Marketed by Avera Mckennan Hospital, this product is identified by NDC 69189-4124 and is authorized under FDA application ANDA078115.

Identification & Billing

NDC Package Code
69189-4124-1
Package Description
1 TABLET, EXTENDED RELEASE in 1 DOSE PACK
Product Code
69189-4124
11-Digit Billing Format
69189412401

Clinical Specifications

Proprietary Name
Carbamazepine
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.

Regulatory & Marketing

Labeler Name
Avera Mckennan Hospital
FDA Application #
ANDA078115
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-27-2015
End Marketing Date
05-24-2017
Listing Expiration
05-24-2017
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 69189-4124-1 identifies a specific commercial package of 1 tablet, extended release in 1 dose pack of Carbamazepine, labeled by Avera Mckennan Hospital. 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 Avera Mckennan Hospital on May 27, 2015. The current certification is valid through May 24, 2017.

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.

How is this Avera Mckennan Hospital product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69189412401. 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)
69189-4124-1
11-Digit CMS (5-4-2)
69189-4124-01

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