Sevelamer Carbonate
NDC Package 67787-407-30

11-digit billing NDC: 67787040730
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.

Sevelamer Carbonate is indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets. Marketed by Invagen Pharmaceuticals Inc., this product is identified by NDC 67787-407 and is authorized under FDA application ANDA203860.

Identification & Billing

NDC Package Code
67787-407-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
67787-407
11-Digit Billing Format
67787040730
RxNorm Crosswalk
RxCUI: 749206 - sevelamer carbonate 800 MG Oral Tablet

Clinical Specifications

Proprietary Name
Sevelamer Carbonate
Dosage Form
-
Usage Information
Sevelamer carbonate is indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis Pediatric use information is approved for Genzyme Corporation’s Renvela (sevelamer carbonate) tablets. However, due to Genzyme Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information

Regulatory & Marketing

Labeler Name
Invagen Pharmaceuticals Inc.
FDA Application #
ANDA203860
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-26-2017
Listing Expiration
12-31-2023
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 (67787-407). Click a package code to view its specific billing and regulatory data.

67787-407-27
270 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 67787-407-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Sevelamer Carbonate, labeled by Invagen Pharmaceuticals Inc.. 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 Invagen Pharmaceuticals Inc. on October 26, 2017. The current certification is valid through December 31, 2023.

How is this Invagen Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67787040730. 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)
67787-407-30
11-Digit CMS (5-4-2)
67787-0407-30

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