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Sevelamer Carbonate

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

Approved
Approval ID

3abc32fe-1bfc-4759-8f7c-36095e221b06

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 7, 2023

Manufacturers
FDA

Winthrop U.S, a business of sanofi-aventis U.S. LLC

DUNS: 824676584

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 Code0955-1050
Application NumberNDA022127
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sevelamer Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 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
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
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 Code0955-1052
Application NumberNDA022318
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sevelamer Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2023
FDA Product Classification

INGREDIENTS (5)

PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 0.8 g in 1 1
Code: 9YCX42I8IU
Classification: ACTIB

Sevelamer Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0955-1054
Application NumberNDA022318
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sevelamer Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2023
FDA Product Classification

INGREDIENTS (5)

FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 2.4 g in 1 1
Code: 9YCX42I8IU
Classification: ACTIB

Sevelamer Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0955-1057
Application NumberNDA022127
Product Classification
M
Marketing Category
C73605
G
Generic Name
Sevelamer Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2023
FDA Product Classification

INGREDIENTS (6)

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

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Sevelamer Carbonate - FDA Drug Approval Details