Lanthanum Carbonate Tablet, Chewable
NDC Package 76282-478-90

11-digit billing NDC: 76282047890 · Billing unit: EA · 90 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lanthanum Carbonate tablets is lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD).Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. This formulation utilizes a tablet, chewable delivery system. Marketed by Exelan Pharmaceuticals, Inc., this product is identified by NDC 76282-478 and is authorized under FDA application ANDA206868.

Identification & Billing

NDC Package Code
76282-478-90
Package Description
9 BOTTLE in 1 PACKAGE / 10 TABLET, CHEWABLE in 1 BOTTLE (76282-478-13)
Product Code
76282-478
11-Digit Billing Format
76282047890
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lanthanum Carbonate
Non-Proprietary Name
Lanthanum Carbonate
Substance Name
Lanthanum Carbonate
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LANTHANUM CARBONATE 1000 mg/1
Pharmacologic Class
Usage Information
Lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD).Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206868
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-25-2022
Listing Expiration
12-31-2027
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 76282-478-90 identifies a specific commercial package of 9 bottle in 1 package / 10 tablet, chewable in 1 bottle (76282-478-13) of Lanthanum Carbonate, a human prescription drug labeled by Exelan Pharmaceuticals, Inc.. This tablet, chewable is formulated for oral use and contains lanthanum carbonate 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 Exelan Pharmaceuticals, Inc. on January 25, 2022. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282047890. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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)
76282-478-90
11-Digit CMS (5-4-2)
76282-0478-90

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