COLESEVELAM HYDROCHLORIDE
These highlights do not include all the information needed to use COLESEVELAM HYDROCHLORIDE safely and effectively. See full prescribing information for COLESEVELAM HYDROCHLORIDE. COLESEVELAM HYDROCHLORIDE tablets, for oral use COLESEVELAM HYDROCHLORIDE for oral suspension Initial U.S. Approval: 2000
Approved
Approval ID
40d66c9d-ff51-4353-8133-ae3a8eb4f713
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
COLESEVELAM HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6994
Application NumberNDA021176
Product Classification
M
Marketing Category
C73594
G
Generic Name
COLESEVELAM HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2022
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 625 mg in 1 1
Code: P4SG24WI5Q
Classification: ACTIB