Lanthanum carbonate
These highlights do not include all the information needed to use LANTHANUM CARBONATE CHEWABLE TABLETS safely and effectively. See full prescribing information for LANTHANUM CARBONATE CHEWABLE TABLETS. LANTHANUM CARBONATE chewable tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
1d5ff930-1189-4e96-bdfb-9fd9c2c83d1b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2023
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-934
Application NumberANDA206868
Product Classification
M
Marketing Category
C73584
G
Generic Name
LANTHANUM CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (9)
LANTHANUM CARBONATEActive
Quantity: 500 mg in 1 1
Code: 490D9F069T
Classification: ACTIM
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LANTHANUM CARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-936
Application NumberANDA206868
Product Classification
M
Marketing Category
C73584
G
Generic Name
LANTHANUM CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (9)
LANTHANUM CARBONATEActive
Quantity: 1000 mg in 1 1
Code: 490D9F069T
Classification: ACTIM
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LANTHANUM CARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-935
Application NumberANDA206868
Product Classification
M
Marketing Category
C73584
G
Generic Name
LANTHANUM CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (9)
LANTHANUM CARBONATEActive
Quantity: 750 mg in 1 1
Code: 490D9F069T
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT