Carbamazepine
NDC Package 68084-445-21

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 American Health Packaging, this product is identified by NDC 68084-445 and is authorized under FDA application NDA020234.

Identification & Billing

NDC Package Code
68084-445-21
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-445-11)
Product Code
68084-445
11-Digit Billing Format
68084044521

Clinical Specifications

Proprietary Name
Carbamazepine ER
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
American Health Packaging
FDA Application #
NDA020234
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
11-01-2011
End Marketing Date
04-13-2012
Listing Expiration
04-13-2012
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 68084-445-21 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack (68084-445-11) of Carbamazepine ER, labeled by American Health Packaging. 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 American Health Packaging on November 01, 2011. The current certification is valid through April 13, 2012.

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 American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68084044521. 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)
68084-445-21
11-Digit CMS (5-4-2)
68084-0445-21

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