MedPath

Triferic

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

Approved
Approval ID

46ec9233-4063-4c48-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 15, 2020

Manufacturers
FDA

Rockwell Medical, Inc

DUNS: 933721433

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

FERRIC PYROPHOSPHATE CITRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57278-315
Application NumberNDA208551
Product Classification
M
Marketing Category
C73594
G
Generic Name
FERRIC PYROPHOSPHATE CITRATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 15, 2020
FDA Product Classification

INGREDIENTS (1)

FERRIC PYROPHOSPHATE CITRATEActive
Quantity: 272 mg in 1 1
Code: UBY79OCO9G
Classification: ACTIM

FERRIC PYROPHOSPHATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57278-314
Application NumberNDA206317
Product Classification
M
Marketing Category
C73594
G
Generic Name
FERRIC PYROPHOSPHATE
Product Specifications
Route of AdministrationHEMODIALYSIS
Effective DateSeptember 15, 2020
FDA Product Classification

INGREDIENTS (1)

FERRIC PYROPHOSPHATE CITRATEActive
Quantity: 5.44 mg in 1 mL
Code: UBY79OCO9G
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Triferic - FDA Drug Approval Details