Lanthanum carbonate
These highlights do not include all the information needed to use LANTHANUM CARBONATE safely and effectively. See full prescribing information for LANTHANUM CARBONATE. LANTHANUM CARBONATE chewable tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
bb263fe8-2bdf-4dba-807f-194f54a73654
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
Products 3
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 Code66993-423
Application NumberNDA021468
Product Classification
M
Marketing Category
C73605
G
Generic Name
LANTHANUM CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 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
LANTHANUM CARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-422
Application NumberNDA021468
Product Classification
M
Marketing Category
C73605
G
Generic Name
LANTHANUM CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (4)
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LANTHANUM CARBONATEActive
Quantity: 500 mg in 1 1
Code: 490D9F069T
Classification: ACTIM
LANTHANUM CARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-424
Application NumberNDA021468
Product Classification
M
Marketing Category
C73605
G
Generic Name
LANTHANUM CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (4)
LANTHANUM CARBONATEActive
Quantity: 1000 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