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
9281598e-60de-4f4f-8e01-0a7dfef92dd3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2018
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-4295
Application NumberNDA021179
Product Classification
M
Marketing Category
C73594
G
Generic Name
Renagel
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2017
FDA Product Classification
INGREDIENTS (9)
SEVELAMER HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: GLS2PGI8QG
Classification: ACTIB
WATERInactive
Quantity: 32.3 mg in 1 1
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Quantity: 8.35 mg in 1 1
Code: R75537T0T4
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
STEARIC ACIDInactive
Quantity: 1.6 mg in 1 1
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Quantity: 8.35 mg in 1 1
Code: 36SFW2JZ0W
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Quantity: 1.6 mg in 1 1
Code: ETJ7Z6XBU4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT