Manufacturing Establishments6
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Eurofins Biopharma Product Testing Ireland Limited
Genzyme Corporation
238239933
Reed-Lane, Inc.
Genzyme Corporation
001819879
EUROAPI UK LIMITED
Genzyme Corporation
229522842
Rovi Pharma Industrial Services SA
Genzyme Corporation
462117953
Sanofi Winthrop Industrie
Genzyme Corporation
763683216
Genzyme Ireland Limited
Genzyme Corporation
985127419
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Renvela
Product Details
NDC Product Code
58468-0131Application Number
NDA022318Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 25, 2023PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 2400 mg in 1 1
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
Renvela
Product Details
NDC Product Code
58468-0132Application Number
NDA022318Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 25, 2023SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1
Renvela
Product Details
NDC Product Code
58468-0130Application Number
NDA022127Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 25, 2023HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Renvela
Product Details
NDC Product Code
58468-0133Application Number
NDA022127Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 25, 2023FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1