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  4. NDC Product Code: 57278-318 Triferic Avnu

NDC 57278-318 Triferic Avnu

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 57278-318?
  5. Triferic Avnu Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
57278-318
Proprietary Name:
Triferic Avnu
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rockwell Medical Inc.
Labeler Code:
57278
Product Label ID:
51197a48-6078-42cd-b5ed-5ea22b6757b4
Start Marketing Date: [9]
03-30-2020
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
GREEN (C48329 - YELLOW-GREEN)

Code Structure Chart

Product Details

What is NDC 57278-318?

The NDC code 57278-318 is assigned by the FDA to the product Triferic Avnu which is product labeled by Rockwell Medical Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 57278-318-02 4 pouch in 1 carton / 10 ampule in 1 pouch (57278-318-01) / 4.5 ml in 1 ampule, 57278-318-11 1 ampule in 1 pouch / 4.5 ml in 1 ampule. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Triferic Avnu?

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.

Which are Triferic Avnu UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Triferic Avnu?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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]

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".