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 suspensionInitial U.S. Approval: 2000
Approved
Approval ID
f33fbf30-2486-49a7-bbe8-0ddfb4b9b786
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2022
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
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 Code0115-1864
Application NumberANDA212886
Product Classification
M
Marketing Category
C73584
G
Generic Name
Colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2022
FDA Product Classification
INGREDIENTS (8)
COLESEVELAM HYDROCHLORIDEActive
Quantity: 3.75 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
LEMONInactive
Code: 24RS0A988O
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT