Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079196022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ezetimibe
Product Details
NDC Product Code
82804-211Application Number
ANDA078560Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 1, 2025EzetimibeActive
Code: EOR26LQQ24Class: ACTIBQuantity: 10 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT