Ferric Citrate Powder
NDC Package 58159-035-01

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.

Ferric Citrate powders is ferric citrate is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. This formulation utilizes a powder delivery system. Marketed by Nuray Chemicals Private Limited, this product is identified by NDC 58159-035.

Identification & Billing

NDC Package Code
58159-035-01
Package Description
35 kg in 1 DRUM
Product Code
58159-035
11-Digit Billing Format
58159003501

Clinical Specifications

Proprietary Name
Ferric Citrate
Non-Proprietary Name
Ferric Citrate
Substance Name
Tetraferric Tricitrate Decahydrate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
TETRAFERRIC TRICITRATE DECAHYDRATE 35 kg/35kg
Usage Information
Ferric citrate 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. This medication works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool. Ferric citrate is a form of iron. This medication is also used to treat low blood levels of iron (anemia) in people with long-term kidney disease who are not on dialysis. Iron is an important mineral that your body needs to produce red blood cells and keep you in good health.

Regulatory & Marketing

Labeler Name
Nuray Chemicals Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-09-2024
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 58159-035-01 identifies a specific commercial package of 35 kg in 1 drum of Ferric Citrate (UNFINISHED drug), a bulk ingredient labeled by Nuray Chemicals Private Limited. This powder is formulated for use and contains tetraferric tricitrate decahydrate 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 Nuray Chemicals Private Limited on December 09, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ferric citrate 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. This medication works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool. Ferric citrate is a form of iron. This medication is also used to treat low blood levels of iron (anemia) in people with long-term kidney disease who are not on dialysis. Iron is an important mineral that your body needs to produce red blood cells and keep you in good health.

How is this Nuray Chemicals Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58159003501. 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)
58159-035-01
11-Digit CMS (5-4-2)
58159-0035-01

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