Welchol
These highlights do not include all the information needed to use WELCHOL safely and effectively. See full prescribing information for WELCHOL. WELCHOL (colesevelam hydrochloride) tablets, for oral use WELCHOL (colesevelam hydrochloride) for oral suspension Initial U.S. Approval: 2000
Approved
Approval ID
4a06d3b2-7229-4398-baba-5d0a72f63821
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 2022
Manufacturers
FDA
Daiichi Sankyo Inc.
DUNS: 068605067
Products 6
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 Code65597-209
Application NumberNDA210895
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2021
FDA Product Classification
INGREDIENTS (10)
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
PALM OILInactive
Code: 5QUO05548Z
Classification: IACT
VANILLA BEANInactive
Code: Q74T35078H
Classification: IACT
ROSEMARYInactive
Code: IJ67X351P9
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
COCOAInactive
Code: D9108TZ9KG
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 3.75 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
colesevelam hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65597-701
Application NumberNDA021176
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2021
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 625 mg in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
colesevelam hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65597-208
Application NumberNDA210895
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2021
FDA Product Classification
INGREDIENTS (11)
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 3.75 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
VANILLA BEANInactive
Code: Q74T35078H
Classification: IACT
ROSEMARYInactive
Code: IJ67X351P9
Classification: IACT
PALM OILInactive
Code: 5QUO05548Z
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
colesevelam hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65597-903
Application NumberNDA022362
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2021
FDA Product Classification
INGREDIENTS (7)
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 1.875 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501T
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
colesevelam hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65597-210
Application NumberNDA210895
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2021
FDA Product Classification
INGREDIENTS (11)
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
PALM OILInactive
Code: 5QUO05548Z
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 3.75 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
ROSEMARYInactive
Code: IJ67X351P9
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
colesevelam hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65597-902
Application NumberNDA022362
Product Classification
M
Marketing Category
C73594
G
Generic Name
colesevelam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2021
FDA Product Classification
INGREDIENTS (7)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501T
Classification: IACT
COLESEVELAM HYDROCHLORIDEActive
Quantity: 3.75 g in 1 1
Code: P4SG24WI5Q
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT