Velphoro Tablet, Chewable
NDC Package 49230-645-51

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

Package Information

Velphoro (sucroferric oxyhydroxide) tablets is sucroferric oxyhydroxide is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. This formulation utilizes a tablet, chewable delivery system. Marketed by Fresenius Medical Care Renal Therapies Group, Llc, this product is identified by NDC 49230-645 and is authorized under FDA application NDA205109.

Identification & Billing

NDC Package Code
49230-645-51
Package Description
1 BOTTLE in 1 CARTON / 90 TABLET, CHEWABLE in 1 BOTTLE
Product Code
49230-645
11-Digit Billing Format
49230064551
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Velphoro
Non-Proprietary Name
Sucroferric Oxyhydroxide
Substance Name
Ferric Oxyhydroxide
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)
FERRIC OXYHYDROXIDE 500 mg/1
Pharmacologic Class
Usage Information
Sucroferric oxyhydroxide is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. Sucroferric oxyhydroxide contains a form of iron which is not absorbed by your body. It works by binding to phosphate in your diet. The phosphate then passes out of your body in your stool.

Regulatory & Marketing

Labeler Name
Fresenius Medical Care Renal Therapies Group, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA205109
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-27-2013
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 49230-645-51 identifies a specific commercial package of 1 bottle in 1 carton / 90 tablet, chewable in 1 bottle of Velphoro, a human prescription drug labeled by Fresenius Medical Care Renal Therapies Group, Llc. This tablet, chewable is formulated for oral use and contains ferric oxyhydroxide 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 Fresenius Medical Care Renal Therapies Group, Llc on November 27, 2013. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Sucroferric oxyhydroxide is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. Sucroferric oxyhydroxide contains a form of iron which is not absorbed by your body. It works by binding to phosphate in your diet. The phosphate then passes out of your body in your stool.

How is this Fresenius Medical Care Renal Therapies Group, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49230064551. 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)
49230-645-51
11-Digit CMS (5-4-2)
49230-0645-51

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