Renagel
These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000
Approved
Approval ID
4a3b3dd8-9b4a-4a00-8178-eb8417195081
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2017
Manufacturers
FDA
DOH CENTRAL PHARMACY
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Renagel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0777
Application NumberNDA021179
Product Classification
M
Marketing Category
C73594
G
Generic Name
Renagel
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2017
FDA Product Classification
INGREDIENTS (9)
SEVELAMER HYDROCHLORIDEActive
Quantity: 800 mg in 1 1
Code: GLS2PGI8QG
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT