NDC 57278-314 Triferic

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
57278-314
Proprietary Name:
Triferic
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rockwell Medical, Inc
Labeler Code:
57278
Start Marketing Date: [9]
02-06-2015
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

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

Product Packages

NDC Code 57278-314-02

Package Description: 8 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

Product Details

What is NDC 57278-314?

The NDC code 57278-314 is assigned by the FDA to the product Triferic which is product labeled by Rockwell Medical, Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 57278-314-02 8 pouch in 1 carton / 5 ampule in 1 pouch / 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?

Triferic 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).

Which are Triferic UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Triferic?

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: 1790866 - ferric pyrophosphate (as iron) 272 MG hemodialysis Injection
  • RxCUI: 1790866 - ferric pyrophosphate citrate 272 MG Injection
  • RxCUI: 1790866 - ferric pyrophosphate (as elemental iron) 272 MG hemodialysis Injection
  • RxCUI: 1790869 - Triferic (iron) 272 MG hemodialysis Injection
  • RxCUI: 1790869 - ferric pyrophosphate citrate 272 MG 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".