Carvedilol Phosphate
NDC Package 60505-4713-3

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 inactivated by the FDA.

Carvedilol Phosphate is extended-release capsules are contraindicated in the following conditions:•Bronchial asthma or related bronchospastic conditions. Marketed by Apotex Corp., this product is identified by NDC 60505-4713 and is authorized under FDA application NDA022012.

Identification & Billing

NDC Package Code
60505-4713-3
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
60505-4713
11-Digit Billing Format
60505471303
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 860510 - carvedilol phosphate 10 MG 24HR Extended Release Oral Capsule
  • RxCUI: 860510 - 24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule
  • RxCUI: 860510 - carvedilol phosphate 10 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 860516 - carvedilol phosphate 20 MG 24HR Extended Release Oral Capsule
  • RxCUI: 860516 - 24 HR carvedilol phosphate 20 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Carvedilol Phosphate
Dosage Form
-
Usage Information
Carvedilol Phosphate extended-release capsules are contraindicated in the following conditions:•Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of immediate-release carvedilol.•Second‑ or third‑degree AV block.•Sick sinus syndrome.•Severe 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 Phosphate extended-release capsules.•Patients with severe hepatic impairment.•Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of Carvedilol Phosphate extended-release capsules.

Regulatory & Marketing

Labeler Name
Apotex Corp.
FDA Application #
NDA022012
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
11-01-2019
Listing Expiration
12-31-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60505-4713-3 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Carvedilol Phosphate, labeled by Apotex Corp.. 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 Apotex Corp. on November 01, 2019. The current certification is valid through December 31, 2022.

How is this Apotex Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505471303. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-4-1)
60505-4713-3
11-Digit CMS (5-4-2)
60505-4713-03

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