Carvedilol
NDC Package 50436-2607-2

11-digit billing NDC: 50436260702
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Carvedilol is tablets are contraindicated in the following conditions:  Bronchial asthma or related bronchospastic conditions. Marketed by Unit Dose Services, this product is identified by NDC 50436-2607 and is authorized under FDA application ANDA078332.

Identification & Billing

NDC Package Code
50436-2607-2
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
50436-2607
11-Digit Billing Format
50436260702
RxNorm Crosswalk
RxCUI: 200031 - carvedilol 6.25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Carvedilol
Dosage Form
-
Usage Information
Carvedilol tablets are contraindicated in the following conditions:  Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of carvedilol tablets.Second- or third-degree AV blockSick sinus syndromeSevere bradycardia (unless a permanent pacemaker is in place)Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating carvedilol tablets.Patients with severe hepatic impairmentPatients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA078332
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-23-2009
Listing Expiration
12-31-2020
Exclude Flag
I
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 (50436-2607). Click a package code to view its specific billing and regulatory data.

50436-2607-4
180 TABLET, FILM COATED 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 50436-2607-2 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Carvedilol, labeled by Unit Dose Services. 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 Unit Dose Services on March 23, 2009. The current certification is valid through December 31, 2020.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436260702. 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)
50436-2607-2
11-Digit CMS (5-4-2)
50436-2607-02

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