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Fosrenol

These highlights do not include all the information needed to use FOSRENOL safely and effectively. See full prescribing information for FOSRENOL. FOSRENOL (lanthanum carbonate) chewable tablets, for oral use FOSRENOL (lanthanum carbonate) oral powder, for oral use Initial U.S. Approval: 2004

Approved
Approval ID

f10776b2-2c25-4343-aabe-68f302e5cb54

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2023

Manufacturers
FDA

Takeda Pharmaceuticals America, Inc.

DUNS: 039997266

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

lanthanum carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54092-254
Application NumberNDA021468
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanthanum carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (4)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LANTHANUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: 490D9F069T
Classification: ACTIM
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT

lanthanum carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54092-253
Application NumberNDA021468
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanthanum carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (4)

LANTHANUM CARBONATEActive
Quantity: 750 mg in 1 1
Code: 490D9F069T
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

lanthanum carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54092-252
Application NumberNDA021468
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanthanum carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (4)

LANTHANUM CARBONATEActive
Quantity: 500 mg in 1 1
Code: 490D9F069T
Classification: ACTIM
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

lanthanum carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54092-257
Application NumberNDA204734
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanthanum carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (4)

DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
LANTHANUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: 490D9F069T
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

lanthanum carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54092-256
Application NumberNDA204734
Product Classification
M
Marketing Category
C73594
G
Generic Name
lanthanum carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (4)

LANTHANUM CARBONATEActive
Quantity: 750 mg in 1 1
Code: 490D9F069T
Classification: ACTIM
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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