NDC 54092-254

Fosrenol

Lanthanum Carbonate

Fosrenol is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Shire Us Manufacturing Inc.. The primary component is Lanthanum Carbonate.

Product ID54092-254_02476a55-c4c2-4af4-8add-099667f82d68
NDC54092-254
Product TypeHuman Prescription Drug
Proprietary NameFosrenol
Generic NameLanthanum Carbonate
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2005-11-23
Marketing CategoryNDA / NDA
Application NumberNDA021468
Labeler NameShire US Manufacturing Inc.
Substance NameLANTHANUM CARBONATE
Active Ingredient Strength1000 mg/1
Pharm ClassesPhosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54092-254-90

9 BOTTLE in 1 PACKAGE (54092-254-90) > 10 TABLET, CHEWABLE in 1 BOTTLE (54092-254-10)
Marketing Start Date2005-11-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-254-10 [54092025410]

Fosrenol TABLET, CHEWABLE
Marketing CategoryNDA
Application NumberNDA021468
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-11-23

NDC 54092-254-90 [54092025490]

Fosrenol TABLET, CHEWABLE
Marketing CategoryNDA
Application NumberNDA021468
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-11-23

Drug Details

Active Ingredients

IngredientStrength
LANTHANUM CARBONATE1000 mg/1

OpenFDA Data

SPL SET ID:f10776b2-2c25-4343-aabe-68f302e5cb54
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 542465
  • 602635
  • 603122
  • 603112
  • 477347
  • 1551881
  • 1551884
  • 1551886
  • 1551885
  • 642452
  • Pharmacological Class

    • Phosphate Binder [EPC]
    • Phosphate Chelating Activity [MoA]

    Medicade Reported Pricing

    54092025490 FOSRENOL 1,000 MG TABLET CHEW

    Pricing Unit: EA | Drug Type:

    54092025410 FOSRENOL 1,000 MG TABLET CHEW

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Fosrenol" or generic name "Lanthanum Carbonate"

    NDCBrand NameGeneric Name
    54092-252Fosrenollanthanum carbonate
    54092-253Fosrenollanthanum carbonate
    54092-254Fosrenollanthanum carbonate
    54092-256Fosrenollanthanum carbonate
    54092-257Fosrenollanthanum carbonate
    0093-5938Lanthanum carbonateLanthanum carbonate
    0093-5939Lanthanum carbonateLanthanum carbonate
    0093-5940Lanthanum carbonateLanthanum carbonate
    66993-422Lanthanum carbonateLANTHANUM CARBONATE
    66993-423Lanthanum carbonateLANTHANUM CARBONATE
    66993-424Lanthanum carbonateLANTHANUM CARBONATE
    68180-819Lanthanum CarbonateLanthanum Carbonate
    68180-820Lanthanum CarbonateLanthanum Carbonate
    68180-821Lanthanum CarbonateLanthanum Carbonate
    69097-934Lanthanum carbonateLANTHANUM CARBONATE
    69097-935Lanthanum carbonateLANTHANUM CARBONATE

    Trademark Results [Fosrenol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FOSRENOL
    FOSRENOL
    77685009 3685795 Dead/Cancelled
    Shire International Licensing BV
    2009-03-06
    FOSRENOL
    FOSRENOL
    76118066 2687871 Live/Registered
    Shire International Licensing BV
    2000-08-28

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