Colesevelam hydrochloride
These highlights do not include all the information needed to use COLESEVELAM HYDROCHLORIDE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for COLESEVELAM HYDROCHLORIDE FOR ORAL SUSPENSION. COLESEVELAM HYDROCHLORIDE for oral suspension Initial U.S. Approval: 2000
Approved
Approval ID
652fbd7b-2702-4db6-8691-be93c61bd9d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 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 hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8860
Application NumberANDA210316
Product Classification
M
Marketing Category
C73584
G
Generic Name
Colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2022
FDA Product Classification
INGREDIENTS (11)
COLESEVELAM HYDROCHLORIDEActive
Quantity: 3.75 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501T
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
LEMONInactive
Code: 24RS0A988O
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT