Criic Pellets, Coated, Extended Release
NDC Package 82646-003-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Criic pelletses is carvedilol is used to treat high blood pressure and heart failure. This formulation utilizes a pellets, coated, extended release delivery system. Marketed by Meribel Pharma Pessac, this product is identified by NDC 82646-003.

Identification & Billing

NDC Package Code
82646-003-01
Package Description
25 kg in 1 DRUM
Product Code
82646-003
11-Digit Billing Format
82646000301

Clinical Specifications

Proprietary Name
Criic
Non-Proprietary Name
Criic
Substance Name
Carvedilol Phosphate
Dosage Form
Pellets, Coated, Extended Release - A solid dosage form in which the drug itself is in the form of granules to which varying amounts of coating have been applied, 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.
Active Ingredient(s)
CARVEDILOL PHOSPHATE 1 kg/kg
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
Meribel Pharma Pessac
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
10-20-2006
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 82646-003-01 identifies a specific commercial package of 25 kg in 1 drum of Criic (UNFINISHED drug), drug for further processing labeled by Meribel Pharma Pessac. This pellets, coated, extended release is formulated for 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 Meribel Pharma Pessac on October 20, 2006. 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 Meribel Pharma Pessac product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82646000301. 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)
82646-003-01
11-Digit CMS (5-4-2)
82646-0003-01

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