NDC 57278-316

Triferic

Ferric Pyrophosphate Citrate

Triferic is a Hemodialysis; Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Rockwell Medical, Inc. The primary component is Ferric Pyrophosphate Citrate.

Product ID57278-316_698459af-84e6-55f5-e053-2a91aa0aac82
NDC57278-316
Product TypeHuman Prescription Drug
Proprietary NameTriferic
Generic NameFerric Pyrophosphate Citrate
Dosage FormSolution
Route of AdministrationHEMODIALYSIS; INTRAVENOUS
Marketing Start Date2015-09-04
Marketing CategoryNDA / NDA
Application NumberNDA206317
Labeler NameRockwell Medical, Inc
Substance NameFERRIC PYROPHOSPHATE CITRATE
Active Ingredient Strength272 mg/50mL
Pharm ClassesIron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57278-316-03

6 POUCH in 1 CARTON (57278-316-03) > 4 AMPULE in 1 POUCH (57278-316-02) > 50 mL in 1 AMPULE (57278-316-01)
Marketing Start Date2015-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57278-316-03 [57278031603]

Triferic SOLUTION
Marketing CategoryNDA
Application NumberNDA206317
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-01

NDC 57278-316-02 [57278031602]

Triferic SOLUTION
Marketing CategoryNDA
Application NumberNDA206317
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-09-04

NDC 57278-316-01 [57278031601]

Triferic SOLUTION
Marketing CategoryNDA
Application NumberNDA206317
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-09-04

Drug Details

Active Ingredients

IngredientStrength
FERRIC PYROPHOSPHATE CITRATE272 mg/50mL

OpenFDA Data

SPL SET ID:46ec9233-4063-4c48-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1855512
  • 1790869
  • 1790866
  • 1855509
  • 1855508
  • 1855513

    • Pharmacological Class

    • Iron [CS]
    • Parenteral Iron Replacement [EPC]
    • Phosphate Binder [EPC]
    • Phosphate Chelating Activity [MoA]

    NDC Crossover Matching brand name "Triferic" or generic name "Ferric Pyrophosphate Citrate"

    NDCBrand NameGeneric Name
    57278-314TrifericFERRIC PYROPHOSPHATE
    57278-315TrifericFERRIC PYROPHOSPHATE CITRATE
    57278-316TrifericFerric Pyrophosphate Citrate
    64811-315TrifericFERRIC PYROPHOSPHATE CITRATE
    57278-318Triferic AVNUferric pyrophosphate citrate
    60940-029Triferic AVNUferric pyrophosphate citrate
    60940-022Triferic Solution for Hemodialysisferric pyrophosphate citrate

    Trademark Results [Triferic]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRIFERIC
    TRIFERIC
    86036014 4837260 Live/Registered
    ROCKWELL MEDICAL, INC.
    2013-08-13
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