NDC 57278-318

Triferic AVNU

Ferric Pyrophosphate Citrate

Triferic AVNU is a 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 ID57278-318_a2a165ea-cb4f-d747-e053-2995a90a9f10
NDC57278-318
Product TypeHuman Prescription Drug
Proprietary NameTriferic AVNU
Generic NameFerric Pyrophosphate Citrate
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-03-30
Marketing CategoryNDA / NDA
Application NumberNDA212860
Labeler NameRockwell Medical Inc.
Substance NameFERRIC PYROPHOSPHATE CITRATE
Active Ingredient Strength2 mg/mL
Pharm ClassesIron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 57278-318-02

4 POUCH in 1 CARTON (57278-318-02) > 10 AMPULE in 1 POUCH (57278-318-01) > 4.5 mL in 1 AMPULE
Marketing Start Date2020-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57278-318-01 [57278031801]

Triferic AVNU SOLUTION
Marketing CategoryNDA
Application NumberNDA212860
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-30

NDC 57278-318-02 [57278031802]

Triferic AVNU SOLUTION
Marketing CategoryNDA
Application NumberNDA212860
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-30

Drug Details

Active Ingredients

IngredientStrength
FERRIC PYROPHOSPHATE CITRATE1.5 mg/mL

OpenFDA Data

SPL SET ID:51197a48-6078-42cd-b5ed-5ea22b6757b4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2287757
  • 2287755

    • Pharmacological Class

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

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

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

    Trademark Results [Triferic AVNU]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRIFERIC AVNU
    TRIFERIC AVNU
    88902817 not registered Live/Pending
    ROCKWELL MEDICAL, INC.
    2020-05-06
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.