Sevelamer carbonate
These highlights do not include all the information needed to use SEVELAMER CARBONATE TABLETS safely and effectively. See full prescribing information for SEVELAMER CARBONATE TABLETS. SEVELAMER CARBONATE tablets, film coated for oral use Initial U.S. Approval: 2000
Approved
Approval ID
40bc25f8-c4f3-4e3a-b120-05adb40e5483
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2017
Manufacturers
FDA
InvaGen Pharmaceuticals Inc.
DUNS: 165104469
Products 1
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 Code67787-407
Application NumberANDA203860
Product Classification
M
Marketing Category
C73584
G
Generic Name
SEVELAMER CARBONATE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2017
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 800 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT