Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sanofi-Aventis U.S. LLC
Lake Erie Medical DBA Quality Care Products LLC
783243835
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fexofenadine Hydrochloride
Product Details
NDC Product Code
49999-772Application Number
ANDA020872Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 7, 2010FexofenadineActive
Code: 2S068B75ZUClass: ACTIBQuantity: 180 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT