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Renvela

These highlights do not include all the information needed to use RENVELA safely and effectively. See full prescribing information for RENVELA. RENVELA (sevelamer carbonate) tablets, for oral use RENVELA (sevelamer carbonate) powder, for oral suspension Initial U.S. Approval: 2000

Approved
Approval ID

e6328460-a57b-450b-a48c-6dcd4b476360

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 25, 2023

Manufacturers
FDA

Genzyme Corporation

DUNS: 025322157

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SEVELAMER CARBONATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58468-0131
Application NumberNDA022318
Product Classification
M
Marketing Category
C73594
G
Generic Name
SEVELAMER CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

INGREDIENTS (5)

PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 2400 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

SEVELAMER CARBONATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58468-0132
Application NumberNDA022318
Product Classification
M
Marketing Category
C73594
G
Generic Name
SEVELAMER CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

INGREDIENTS (5)

SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 800 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB

SEVELAMER CARBONATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58468-0130
Application NumberNDA022127
Product Classification
M
Marketing Category
C73594
G
Generic Name
SEVELAMER CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

INGREDIENTS (7)

HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 800 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT

SEVELAMER CARBONATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58468-0133
Application NumberNDA022127
Product Classification
M
Marketing Category
C73594
G
Generic Name
SEVELAMER CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

INGREDIENTS (7)

FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 800 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB

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Renvela - FDA Drug Approval Details