Tegretol Suspension
NDC Package 0078-0508-83

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tegretol (carbamazepine) suspension is carbamazepine is used to prevent and control seizures. This formulation utilizes a suspension delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0508 and is authorized under FDA application NDA018927.

Identification & Billing

NDC Package Code
0078-0508-83
Package Description
450 mL in 1 BOTTLE
Product Code
0078-0508
11-Digit Billing Format
00078050883
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
450 ML
RxNorm Crosswalk
  • RxCUI: 199378 - carBAMazepine 100 MG 12HR Extended Release Oral Tablet
  • RxCUI: 199378 - 12 HR carbamazepine 100 MG Extended Release Oral Tablet
  • RxCUI: 199378 - carbamazepine 100 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 308971 - Tegretol 100 MG in 5 mL Oral Suspension
  • RxCUI: 308971 - carbamazepine 20 MG/ML Oral Suspension [Tegretol]

Clinical Specifications

Proprietary Name
Tegretol
Non-Proprietary Name
Carbamazepine
Substance Name
Carbamazepine
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARBAMAZEPINE 100 mg/5mL
Pharmacologic Class
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 Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA018927
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-18-1987
Listing Expiration
12-31-2026
Exclude Flag
N
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 0078-0508-83 identifies a specific commercial package of 450 ml in 1 bottle of Tegretol, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This suspension is formulated for oral 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 Pharmaceuticals Corporation on December 18, 1987. 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 Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078050883. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 450 total billable units per package. 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 (4-4-2)
0078-0508-83
11-Digit CMS (5-4-2)
00078-0508-83

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