Coreg Cr Capsule, Extended Release
NDC Package 80725-385-13

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

Package Information

Coreg Cr (carvedilol phosphate) capsules is carvedilol is used to treat high blood pressure and heart failure. This formulation utilizes a capsule, extended release delivery system. Marketed by Waylis Therapeutics Llc, this product is identified by NDC 80725-385 and is authorized under FDA application NDA022012.

Identification & Billing

NDC Package Code
80725-385-13
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
80725-385
11-Digit Billing Format
80725038513
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: 860512 - COREG CR 10 MG 24HR Extended Release Oral Capsule
  • RxCUI: 860512 - 24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule [Coreg]

Clinical Specifications

Proprietary Name
Coreg Cr
Non-Proprietary Name
Carvedilol Phosphate
Substance Name
Carvedilol Phosphate
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARVEDILOL PHOSPHATE 20 mg/1
Pharmacologic Class
Usage Information
Carvedilol is used to treat high blood pressure and heart failure. It is also used after a heart attack to improve the chance of survival if your heart is not pumping well. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This drug works by blocking the action of certain natural substances in your body, such as epinephrine, on the heart and blood vessels. This effect lowers your heart rate, blood pressure, and strain on your heart. Carvedilol belongs to a class of drugs known as alpha and beta blockers.

Regulatory & Marketing

Labeler Name
Waylis Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022012
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-07-2022
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 80725-385-13 identifies a specific commercial package of 30 capsule, extended release in 1 bottle, plastic of Coreg Cr, a human prescription drug labeled by Waylis Therapeutics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This capsule, extended release is formulated for oral use and contains carvedilol phosphate 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 Waylis Therapeutics Llc on November 07, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Carvedilol is used to treat high blood pressure and heart failure. It is also used after a heart attack to improve the chance of survival if your heart is not pumping well. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This drug works by blocking the action of certain natural substances in your body, such as epinephrine, on the heart and blood vessels. This effect lowers your heart rate, blood pressure, and strain on your heart. Carvedilol belongs to a class of drugs known as alpha and beta blockers.

How is this Waylis Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80725038513. 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 (5-3-2)
80725-385-13
11-Digit CMS (5-4-2)
80725-0385-13

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