Manufacturing Establishments4
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Reed-Lane, Inc.
Winthrop U.S, a business of sanofi-aventis U.S. LLC
001819879
EUROAPI UK LIMITED
Winthrop U.S, a business of sanofi-aventis U.S. LLC
229522842
Eurofins Biopharma Product Testing Ireland Limited
Winthrop U.S, a business of sanofi-aventis U.S. LLC
238239933
Genzyme Ireland Limited
Winthrop U.S, a business of sanofi-aventis U.S. LLC
985127419
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sevelamer Hydrochloride
Product Details
NDC Product Code
0955-1048Application Number
NDA021179Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
December 16, 2022HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SevelamerActive
Code: GLS2PGI8QGClass: ACTIBQuantity: 800 mg in 1 1
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT