SEVELAMER CARBONATE
These highlights do not include all the information needed to use SEVELAMER CARBONATE TABLETS safely and effectively. See full prescribing information for SEVELAMER CARBONATE TABLETS. SEVELAMER CARBONATE tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
9977f652-b3e7-43bc-bf3f-1f54698c5f7a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2022
Manufacturers
FDA
Micro Labs Limited
DUNS: 862174955
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SEVELAMER CARBONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42571-378
Application NumberANDA215537
Product Classification
M
Marketing Category
C73584
G
Generic Name
SEVELAMER CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2022
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 800 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT