Carbamazepine Tablet
NDC Package 60290-008-01

11-digit billing NDC: 60290000801
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Carbamazepine tablets is carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. This formulation utilizes a tablet delivery system. Marketed by Umedica Laboratories Usa Inc., this product is identified by NDC 60290-008 and is authorized under FDA application ANDA207798.

Identification & Billing

NDC Package Code
60290-008-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
60290-008
11-Digit Billing Format
60290000801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Carbamazepine
Non-Proprietary Name
Carbamazepine
Substance Name
Carbamazepine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARBAMAZEPINE 200 mg/1
Pharmacologic Class
Usage Information
Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.

Regulatory & Marketing

Labeler Name
Umedica Laboratories Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207798
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-21-2020
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (60290-008). Click a package code to view its specific billing and regulatory data.

60290-008-02
1000 TABLET in 1 BOTTLE

* 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 60290-008-01 identifies a specific commercial package of 100 tablet in 1 bottle of Carbamazepine, a human prescription drug labeled by Umedica Laboratories Usa Inc.. This tablet 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 Umedica Laboratories Usa Inc. on April 21, 2020. The current certification is valid through December 31, 2027.

How is this Umedica Laboratories Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60290000801. 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)
60290-008-01
11-Digit CMS (5-4-2)
60290-0008-01

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