FDA.reportPublic FDA data

Fosrenol

Product NDC
54092-257
11-digit product format
540920257
Labeler code
54092
Product ID
54092-257_b29f2b53-6f45-447d-afb3-297ccc4ef8db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lanthanum carbonate
Dosage form
POWDER
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA204734
Marketing category
NDA
Marketing start
2014-09-24
Substance
LANTHANUM CARBONATE
Active strength
1000 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fosrenol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANTHANUM CARBONATE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii490D9F069T
Rxcui477347, 542465, 602635, 603112, 603122, 642452, 1551881, 1551884, 1551885, 1551886

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd999b70-ef95-1812-9f06-f589ecff7593Product name520251216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54092-257-01Fosrenol10 in 1 CARTONPOWDER1058
54092-257-02Fosrenol9 in 1 CARTONPOWDER958

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-257-01EA - Each54092-257e8c0ba42-92bf-4b01-85cc-7b17055003c112016-04-04
54092-257-02EA - Each54092-2573dc5c4f9-a7da-4ab1-9d35-4681fc169d1012015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANTHANUM CARBONATEACTIVE INGREDIENT490D9F069TFOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39
LANTHANUM CATION (3+)ACTIVE MOIETYO7FU5X12W5FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39
DEXTRATESINACTIVE INGREDIENTG263MI44RUFOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-257FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [TAKEDA PHARMACEUTICALS AMERICA, INC.]58Current NDC, Legacy NDC, 2 package rows20250406_f10776b2-2c25-4343-aabe-68f302e5cb54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603112FOSRENOL 1000 MG Chewable TabletPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
1551884Fosrenol 1000 MG Oral PowderPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
542465FOSRENOL 500 MG Chewable TabletPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
603122FOSRENOL 750 MG Chewable TabletPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
1551886Fosrenol 750 MG Oral PowderPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
602635lanthanum carbonate 1000 MG Chewable TabletPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
1551881lanthanum carbonate 1000 MG Oral PowderPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
477347lanthanum carbonate 500 MG Chewable TabletPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
642452lanthanum carbonate 750 MG Chewable TabletPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
1551885lanthanum carbonate 750 MG Oral PowderPSNf10776b2-2c25-4343-aabe-68f302e5cb5458
603112lanthanum carbonate 1000 MG Chewable Tablet [Fosrenol]SBDf10776b2-2c25-4343-aabe-68f302e5cb5458
1551884lanthanum carbonate 1000 MG Oral Powder [Fosrenol]SBDf10776b2-2c25-4343-aabe-68f302e5cb5458
542465lanthanum carbonate 500 MG Chewable Tablet [Fosrenol]SBDf10776b2-2c25-4343-aabe-68f302e5cb5458
603122lanthanum carbonate 750 MG Chewable Tablet [Fosrenol]SBDf10776b2-2c25-4343-aabe-68f302e5cb5458
1551886lanthanum carbonate 750 MG Oral Powder [Fosrenol]SBDf10776b2-2c25-4343-aabe-68f302e5cb5458
602635lanthanum carbonate 1000 MG Chewable TabletSCDf10776b2-2c25-4343-aabe-68f302e5cb5458
1551881lanthanum carbonate 1000 MG Oral PowderSCDf10776b2-2c25-4343-aabe-68f302e5cb5458
477347lanthanum carbonate 500 MG Chewable TabletSCDf10776b2-2c25-4343-aabe-68f302e5cb5458
642452lanthanum carbonate 750 MG Chewable TabletSCDf10776b2-2c25-4343-aabe-68f302e5cb5458
1551885lanthanum carbonate 750 MG Oral PowderSCDf10776b2-2c25-4343-aabe-68f302e5cb5458
603112Fosrenol 1,000 MG Chewable TabletSYf10776b2-2c25-4343-aabe-68f302e5cb5458
1551884Fosrenol 1000 MG Oral PowderSYf10776b2-2c25-4343-aabe-68f302e5cb5458
542465Fosrenol 500 MG Chewable TabletSYf10776b2-2c25-4343-aabe-68f302e5cb5458
603122Fosrenol 750 MG Chewable TabletSYf10776b2-2c25-4343-aabe-68f302e5cb5458
1551886Fosrenol 750 MG Oral PowderSYf10776b2-2c25-4343-aabe-68f302e5cb5458

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54092-257-015409202570110 in 1 CARTONHistorical
54092-257-02540920257029 CARTON in 1 CARTON (54092-257-02) / 10 POWDER in 1 CARTON (54092-257-01) 9 carton2014-09-240000-00-00NoNoCurrent