sevelamer hydrochloride
These highlights do not include all the information needed to use SEVELAMER HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SEVELAMER HYDROCHLORIDE TABLETS.SEVELAMER HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
2cd6512f-0edd-4a30-a4fa-aa996038633c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2020
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sevelamer hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-447
Application NumberANDA204724
Product Classification
M
Marketing Category
C73584
G
Generic Name
sevelamer hydrochloride
Product Specifications
Route of AdministrationPARENTERAL
Effective DateJune 30, 2020
FDA Product Classification
INGREDIENTS (16)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SEVELAMER HYDROCHLORIDEActive
Quantity: 800 mg in 1 1
Code: GLS2PGI8QG
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
sevelamer hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-446
Application NumberANDA204724
Product Classification
M
Marketing Category
C73584
G
Generic Name
sevelamer hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2020
FDA Product Classification
INGREDIENTS (16)
SEVELAMER HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: GLS2PGI8QG
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT