NDC 57278-315

Triferic

Ferric Pyrophosphate Citrate

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

Product ID57278-315_698459af-84e6-55f5-e053-2a91aa0aac82
NDC57278-315
Product TypeHuman Prescription Drug
Proprietary NameTriferic
Generic NameFerric Pyrophosphate Citrate
Dosage FormPowder
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-04-25
Marketing CategoryNDA / NDA
Application NumberNDA208551
Labeler NameRockwell Medical, Inc
Substance NameFERRIC PYROPHOSPHATE CITRATE
Active Ingredient Strength272 mg/1
Pharm ClassesIron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57278-315-02

100 PACKET in 1 CARTON (57278-315-02) > 1 POWDER in 1 PACKET
Marketing Start Date2016-04-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57278-315-02 [57278031502]

Triferic POWDER
Marketing CategoryNDA
Application NumberNDA208551
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-25

Drug Details

Active Ingredients

IngredientStrength
FERRIC PYROPHOSPHATE CITRATE272 mg/1

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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.