Colesevelam Hydrochloride
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
87bf6310-cfc4-4cb4-966e-8561b3880e36
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-385
Application NumberANDA091600
Product Classification
M
Marketing Category
C73584
G
Generic Name
Colesevelam Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 625 mg in 1 1
Code: P4SG24WI5Q
Classification: ACTIB