Colesevelam HCL
These highlights do not include all the information needed to use COLESEVELAM HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for COLESEVELAM HYDROCHLORIDE TABLETS. COLESEVELAM HYDROCHLORIDE tablets, for oral use. Initial U.S. Approval: 2000
Approved
Approval ID
5d1b8dfd-cfe7-4c86-9d7b-a709b593acf7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Colesevelam HCL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8767
Application NumberANDA209038
Product Classification
M
Marketing Category
C73584
G
Generic Name
Colesevelam HCL
Product Specifications
Route of AdministrationORAL
Effective DateNovember 26, 2021
FDA Product Classification
INGREDIENTS (11)
COLESEVELAM HYDROCHLORIDEActive
Quantity: 625 mg in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT