Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cedax
Product Details
NDC Product Code
59630-821Application Number
NDA050686Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 12, 2010silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
CeftibutenActive
Code: 62F4443RWPClass: ACTIBQuantity: 18 mg in 1 mL
xanthan gumInactive
Code: TTV12P4NEEClass: IACT
sucroseInactive
Code: C151H8M554Class: IACTQuantity: 1 g in 5 mL
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
sodium benzoateInactive
Code: OJ245FE5EUClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Cedax
Product Details
NDC Product Code
59630-820Application Number
NDA050685Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 12, 2010CeftibutenActive
Code: 62F4443RWPClass: ACTIBQuantity: 400 mg in 1 1
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
methylparabenInactive
Code: A2I8C7HI9TClass: IACT
gelatinInactive
Code: 2G86QN327LClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
benzyl alcoholInactive
Code: LKG8494WBHClass: IACT
sodium propionateInactive
Code: DK6Y9P42INClass: IACT
propylparabenInactive
Code: Z8IX2SC1OHClass: IACT
edetate calcium disodiumInactive
Code: 25IH6R4SGFClass: IACT
butylparabenInactive
Code: 3QPI1U3FV8Class: IACT