Carbamazepine Tablet, Extended Release
NDC Package 66828-0261-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Carbamazepine tablets is carbamazepine is used to prevent and control seizures. This formulation utilizes a tablet, extended release delivery system. Marketed by Novartis Pharma Produktions Gmbh, this product is identified by NDC 66828-0261.

Identification & Billing

NDC Package Code
66828-0261-1
Package Description
25000 TABLET, EXTENDED RELEASE in 1 DRUM
Product Code
66828-0261
11-Digit Billing Format
66828026101

Clinical Specifications

Proprietary Name
Carbamazepine
Non-Proprietary Name
Carbamazepine
Substance Name
Carbamazepine
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Active Ingredient(s)
CARBAMAZEPINE 200 mg/1
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
Novartis Pharma Produktions Gmbh
Product Type
Human Prescription Drug
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
03-25-1996
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 66828-0261-1 identifies a specific commercial package of 25000 tablet, extended release in 1 drum of Carbamazepine (UNFINISHED drug), a human prescription drug labeled by Novartis Pharma Produktions Gmbh. This tablet, extended release is formulated for use and contains carbamazepine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharma Produktions Gmbh on March 25, 1996. The current certification is valid through December 31, 2026.

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 Novartis Pharma Produktions Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66828026101. 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)
66828-0261-1
11-Digit CMS (5-4-2)
66828-0261-01

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