NDC 54092-257

Fosrenol

Lanthanum Carbonate

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

Product ID54092-257_02476a55-c4c2-4af4-8add-099667f82d68
NDC54092-257
Product TypeHuman Prescription Drug
Proprietary NameFosrenol
Generic NameLanthanum Carbonate
Dosage FormPowder
Route of AdministrationORAL
Marketing Start Date2014-09-24
Marketing CategoryNDA / NDA
Application NumberNDA204734
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 54092-257-02

9 CARTON in 1 CARTON (54092-257-02) > 10 POWDER in 1 CARTON (54092-257-01)
Marketing Start Date2014-09-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-257-02 [54092025702]

Fosrenol POWDER
Marketing CategoryNDA
Application NumberNDA204734
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-24

NDC 54092-257-01 [54092025701]

Fosrenol POWDER
Marketing CategoryNDA
Application NumberNDA204734
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-11

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]