Triferic Avnu
NDC 57278-318
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Triferic Avnu is a NDA-approved product labeled by Rockwell Medical Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a green product. This product entry covers the primary NDC 57278-318 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
57278-318
Proprietary Name:
Triferic Avnu
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
57278
Product Label ID:
FDA Application Number: [6]
NDA212860
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
03-30-2020
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
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. This pharmaceutical product is labeled by Rockwell Medical Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 57278-318-02, 57278-318-11. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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 the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- FERRIC PYROPHOSPHATE CITRATE (UNII: UBY79OCO9G)
- FERRIC CATION (UNII: 91O4LML611) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
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]
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
