NDC 57278-318-01 - Triferic AVNU

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 57278-318
Requested NDC: 57278-318-01
Package NDCs from labels: 57278-318-01, 57278-318-02, 57278-318-11
Manufacturer: Rockwell Medical Inc.
Effective date: 2020-09-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Triferic AVNU - Rockwell Medical Inc.	Rockwell Medical Inc.	2020-09-15	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57278-318-02	2023-01-30	C162847	48780-1	f386c64a-279b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRIFERIC AVNU safely and effectively. See full prescribing information for TRIFERIC AVNU. TRIFERIC ® AVNU (ferric pyrophosphate citrate injection), for intravenous use Initial U.S. Approval: 2015
57278-318-11	2023-01-30	C162847	48780-1	f386c64a-279b-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRIFERIC AVNU safely and effectively. See full prescribing information for TRIFERIC AVNU. TRIFERIC ® AVNU (ferric pyrophosphate citrate injection), for intravenous use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57278-318-01	Triferic AVNU	10 in 1 POUCH	SOLUTION	10	3
57278-318-01	Triferic AVNU	4.5 mL in 1 AMPULE	SOLUTION	4.5	3
57278-318-02	Triferic AVNU	4 in 1 CARTON	SOLUTION	4	3
57278-318-11	Triferic AVNU	4.5 mL in 1 AMPULE	SOLUTION	4.5	3
57278-318-11	Triferic AVNU	1 in 1 POUCH	SOLUTION	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57278-318	TRIFERIC AVNU (FERRIC PYROPHOSPHATE CITRATE) SOLUTION [ROCKWELL MEDICAL INC.]	3	Legacy NDC, 5 package rows	20200916_51197a48-6078-42cd-b5ed-5ea22b6757b4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
af5e4041-2fca-6927-e053-2995a90aa402			51197a48-6078-42cd-b5ed-5ea22b6757b4	2020-09-15	Warnings, Adverse reactions	Exact identifier spl id: af5e4041-2fca-6927-e053-2995a90aa402 spl set id: 51197a48-6078-42cd-b5ed-5ea22b6757b4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.