Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Powdersize, LLC
Daiichi Sankyo Inc.
080120056
Products6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Welchol
Product Details
NDC Product Code
65597-209Application Number
NDA210895Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 26, 2021MALTITOLInactive
Code: D65DG142WKClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
PALM OILInactive
Code: 5QUO05548ZClass: IACT
VANILLA BEANInactive
Code: Q74T35078HClass: IACT
ROSEMARYInactive
Code: IJ67X351P9Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
COCOAInactive
Code: D9108TZ9KGClass: IACT
ColesevelamActive
Code: P4SG24WI5QClass: ACTIBQuantity: 3.75 g in 1 1
Welchol
Product Details
NDC Product Code
65597-701Application Number
NDA021176Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 26, 2021MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
ColesevelamActive
Code: P4SG24WI5QClass: ACTIBQuantity: 625 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Welchol
Product Details
NDC Product Code
65597-208Application Number
NDA210895Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 26, 2021MALTITOLInactive
Code: D65DG142WKClass: IACT
ColesevelamActive
Code: P4SG24WI5QClass: ACTIBQuantity: 3.75 g in 1 1
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
VANILLA BEANInactive
Code: Q74T35078HClass: IACT
ROSEMARYInactive
Code: IJ67X351P9Class: IACT
PALM OILInactive
Code: 5QUO05548ZClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
CARAMELInactive
Code: T9D99G2B1RClass: IACT
Welchol
Product Details
NDC Product Code
65597-903Application Number
NDA022362Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 26, 2021GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85Class: IACT
ColesevelamActive
Code: P4SG24WI5QClass: ACTIBQuantity: 1.875 g in 1 1
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501TClass: IACT
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
Welchol
Product Details
NDC Product Code
65597-210Application Number
NDA210895Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 26, 2021MALTITOLInactive
Code: D65DG142WKClass: IACT
PALM OILInactive
Code: 5QUO05548ZClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
ColesevelamActive
Code: P4SG24WI5QClass: ACTIBQuantity: 3.75 g in 1 1
ROSEMARYInactive
Code: IJ67X351P9Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
Welchol
Product Details
NDC Product Code
65597-902Application Number
NDA022362Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 26, 2021CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501TClass: IACT
ColesevelamActive
Code: P4SG24WI5QClass: ACTIBQuantity: 3.75 g in 1 1
ASPARTAMEInactive
Code: Z0H242BBR1Class: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85Class: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT