Sevelamer Hydrochloride
These highlights do not include all the information needed to use SEVELAMER HYDROCHLORIDE safely and effectively. See full prescribing information for SEVELAMER HYDROCHLORIDE. SEVELAMER HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
5a76bd76-a6cc-46f1-bb58-660566eaec06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2022
Manufacturers
FDA
Winthrop U.S, a business of sanofi-aventis U.S. LLC
DUNS: 824676584
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sevelamer Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-1048
Application NumberNDA021179
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sevelamer Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2022
FDA Product Classification
INGREDIENTS (6)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SEVELAMER HYDROCHLORIDEActive
Quantity: 800 mg in 1 1
Code: GLS2PGI8QG
Classification: ACTIB
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT