Cedax
CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension)
Approved
Approval ID
2dd58c88-142f-41ad-bc31-0a4fff074970
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2010
Manufacturers
FDA
Sciele Pharma, Inc.
DUNS: 802728477
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ceftibuten dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59630-821
Application NumberNDA050686
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ceftibuten dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2010
FDA Product Classification
INGREDIENTS (7)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Ceftibuten dihydrateActive
Quantity: 18 mg in 1 mL
Code: 62F4443RWP
Classification: ACTIB
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
sucroseInactive
Quantity: 1 g in 5 mL
Code: C151H8M554
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ceftibuten dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59630-820
Application NumberNDA050685
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ceftibuten dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2010
FDA Product Classification
INGREDIENTS (11)
Ceftibuten dihydrateActive
Quantity: 400 mg in 1 1
Code: 62F4443RWP
Classification: ACTIB
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
sodium propionateInactive
Code: DK6Y9P42IN
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
edetate calcium disodiumInactive
Code: 25IH6R4SGF
Classification: IACT
butylparabenInactive
Code: 3QPI1U3FV8
Classification: IACT