Triferic Avnu
NDC Package 57278-318-11

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Triferic Avnu is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). Marketed by Rockwell Medical Inc., this product is identified by NDC 57278-318 and is authorized under FDA application NDA212860.

Identification & Billing

NDC Package Code
57278-318-11
Package Description
1 AMPULE in 1 POUCH / 4.5 mL in 1 AMPULE
Product Code
57278-318
11-Digit Billing Format
57278031811
RxNorm Crosswalk
  • RxCUI: 2287755 - ferric pyrophosphate citrate (as iron) 6.75 MG in 4.5 mL hemodialysis Injection
  • RxCUI: 2287755 - 4.5 ML ferric pyrophosphate citrate 1.5 MG/ML Injection
  • RxCUI: 2287755 - ferric pyrophosphate citrate (as elemental iron) 6.75 MG per 4.5 ML hemodialysis Injection
  • RxCUI: 2287757 - Triferic (iron) 6.75 MG in 4.5 mL hemodialysis Injection
  • RxCUI: 2287757 - 4.5 ML ferric pyrophosphate citrate 1.5 MG/ML Injection [Triferic]

Clinical Specifications

Proprietary Name
Triferic Avnu
Dosage Form
-
Usage Information
Triferic AVNU is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). Limitations of UseTriferic AVNU is not intended for use in patients receiving peritoneal dialysis. Triferic AVNU  has not been studied in patients receiving home hemodialysis.

Regulatory & Marketing

Labeler Name
Rockwell Medical Inc.
FDA Application #
NDA212860
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-30-2020
Listing Expiration
12-31-2022
Exclude Flag
I
Sample Package
Yes

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 (57278-318). Click a package code to view its specific billing and regulatory data.

57278-318-02
4 POUCH in 1 CARTON / 10 AMPULE in 1 POUCH (57278-318-01) / 4.5 mL in 1 AMPULE

* 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 57278-318-11 identifies a specific commercial package of 1 ampule in 1 pouch / 4.5 ml in 1 ampule of Triferic Avnu, labeled by Rockwell Medical 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 Rockwell Medical Inc. on March 30, 2020. The current certification is valid through December 31, 2022.

How is this Rockwell Medical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57278031811. 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)
57278-318-11
11-Digit CMS (5-4-2)
57278-0318-11

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