NDC 59922-631

Auryxia

Ferric Citrate

Auryxia is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Akebia Therapeutics, Inc.. The primary component is Tetraferric Tricitrate Decahydrate.

Product ID59922-631_122f6283-fd52-424c-b174-e7a3bde61742
NDC59922-631
Product TypeHuman Prescription Drug
Proprietary NameAuryxia
Generic NameFerric Citrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-09-17
Marketing CategoryNDA / NDA
Application NumberNDA205874
Labeler NameAkebia Therapeutics, Inc.
Substance NameTETRAFERRIC TRICITRATE DECAHYDRATE
Active Ingredient Strength210 mg/1
Pharm ClassesIron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59922-631-01

200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01)
Marketing Start Date2014-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59922-631-01 [59922063101]

Auryxia TABLET, COATED
Marketing CategoryNDA
Application NumberNDA205874
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-17

NDC 59922-631-91 [59922063191]

Auryxia TABLET, COATED
Marketing CategoryNDA
Application NumberNDA205874
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-17
Marketing End Date2019-12-20

NDC 59922-631-92 [59922063192]

Auryxia TABLET, COATED
Marketing CategoryNDA
Application NumberNDA205874
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-17
Marketing End Date2019-12-20

Drug Details

Active Ingredients

IngredientStrength
TETRAFERRIC TRICITRATE DECAHYDRATE210 mg/1

OpenFDA Data

SPL SET ID:aadd18e0-3752-11e4-8510-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1596023
  • 1594680
  • UPC Code
  • 0359922631916
  • Pharmacological Class

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

    Medicade Reported Pricing

    59922063101 AURYXIA 210 MG TABLET

    Pricing Unit: EA | Drug Type:

    Trademark Results [Auryxia]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AURYXIA
    AURYXIA
    86390566 4956680 Live/Registered
    Keryx Biopharmaceuticals, Inc.
    2014-09-10

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