NDC 54092-252

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 ID54092-252_02476a55-c4c2-4af4-8add-099667f82d68
NDC54092-252
Product TypeHuman Prescription Drug
Proprietary NameFosrenol
Generic NameLanthanum Carbonate
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2004-10-26
Marketing CategoryNDA / NDA
Application NumberNDA021468
Labeler NameShire US Manufacturing Inc.
Substance NameLANTHANUM CARBONATE
Active Ingredient Strength500 mg/1
Pharm ClassesPhosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54092-252-90

2 BOTTLE in 1 PACKAGE (54092-252-90) > 45 TABLET, CHEWABLE in 1 BOTTLE (54092-252-45)
Marketing Start Date2004-10-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-252-90 [54092025290]

Fosrenol TABLET, CHEWABLE
Marketing CategoryNDA
Application NumberNDA021468
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-10-26

NDC 54092-252-45 [54092025245]

Fosrenol TABLET, CHEWABLE
Marketing CategoryNDA
Application NumberNDA021468
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-10-26

Drug Details

Active Ingredients

IngredientStrength
LANTHANUM CARBONATE500 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

    54092025290 FOSRENOL 500 MG TABLET CHEW

    Pricing Unit: EA | Drug Type:

    54092025245 FOSRENOL 500 MG TABLET CHEW

    Pricing Unit: EA | Drug Type: