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
09b5e422-18c9-49dc-be3d-5d24648184af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2022
Manufacturers
FDA
Precision Dose, Inc.
DUNS: 035886746
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 Code68094-034
Application NumberANDA207288
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sevelamer Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (10)
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Zinc StearateInactive
Code: H92E6QA4FV
Classification: IACT
AmmoniaInactive
Code: 5138Q19F1X
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 800 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT