NDC 57278-314-01 - Triferic

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: 57278-314
Requested NDC: 57278-314-01
Package NDCs from labels: 57278-314-02, 57278-314-01
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 - Rockwell Medical, Inc	Rockwell Medical, Inc	2020-09-15	HUMAN PRESCRIPTION DRUG LABEL
Triferic - Rockwell Medical, Inc	Rockwell Medical, Inc	2016-05-06	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57278-314-02	2023-01-30	C162847	48780-1	f386c649-ea67-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TRIFERIC safely and effectively. See full prescribing information for TRIFERIC. TRIFERIC ® (ferric pyrophosphate citrate) solution, for hemodialysis use TRIFERIC ® (ferric pyrophosphate citrate) for solution, for hemodialysis use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57278-314-02	Triferic	5 in 1 POUCH	SOLUTION	5		14
57278-314-02	Triferic	8 in 1 CARTON	SOLUTION	8		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57278-314	TRIFERIC (FERRIC PYROPHOSPHATE) SOLUTION TRIFERIC (FERRIC PYROPHOSPHATE CITRATE) POWDER [ROCKWELL MEDICAL, INC]	14	Legacy NDC, 2 package rows	20200916_46ec9233-4063-4c48-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57278-314-01	ML - Milliliter	57278-314	11d9f360-f6cf-4424-a7a5-f0f909110dac	1	2019-06-19
57278-314-02	ML - Milliliter	57278-314	27d1b3fb-4bf8-4069-8aa4-93527903fa5d	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
FERRIC PYROPHOSPHATE CITRATE	ACTIVE INGREDIENT	UBY79OCO9G	TRIFERIC (FERRIC PYROPHOSPHATE) SOLUTION [ROCKWELL MEDICAL, INC]	2
FERRIC CATION	ACTIVE MOIETY	91O4LML611	TRIFERIC (FERRIC PYROPHOSPHATE) SOLUTION [ROCKWELL MEDICAL, INC]	2

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
af5e96dc-661a-5180-e053-2a95a90a6edc			46ec9233-4063-4c48-e054-00144ff8d46c	2020-09-15	Warnings, Adverse reactions	Exact identifier spl id: af5e96dc-661a-5180-e053-2a95a90a6edc spl set id: 46ec9233-4063-4c48-e054-00144ff8d46c
32308a79-be24-62ae-e054-00144ff88e88			bef06c1f-eda6-4cfa-a578-379f23964599	2016-05-06	Warnings, Adverse reactions	Exact identifier spl id: 32308a79-be24-62ae-e054-00144ff88e88 spl set id: bef06c1f-eda6-4cfa-a578-379f23964599

Reported adverse events (FAERS/openFDA)#

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