Colesevelam hydrochloride

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

27808-190

Application Number

ANDA209946

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 30, 2022

Ingredients

Code: P4SG24WI5QClass: ACTIBQuantity: 625 mg in 1 1

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

DIACETYLATED MONOGLYCERIDESInactive

Code: 5Z17386USFClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT