Ezetimibe

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

A-S Medication Solutions

DUNS Number

830016429

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

NDC Product Code

50090-3657

Application Number

ANDA209234

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 23, 2022

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT