NDC Code(s) : 44183-400-22, 44183-180-30, 44183-180-02
Packager : Macoven Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ceftibutenceftibuten dihydrate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44183-400
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ceftibuten dihydrate(UNII: 62F4443RWP)
(CEFTIBUTEN - UNII:IW71N46B4Y) 		CEFTIBUTEN400 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM PROPIONATE(UNII: DK6Y9P42IN)
EDETATE CALCIUM DISODIUM(UNII: 25IH6R4SGF)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
METHYLPARABEN(UNII: A2I8C7HI9T)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code 400;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:44183-400-2220 in 1 BOTTLE Type 0: Not a Combination Product01/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA050685 10/01/2013 12/31/2017
CeftibutenCEFTIBUTEN DIHYDRATE SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44183-180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTIBUTEN DIHYDRATE(UNII: 62F4443RWP)
(CEFTIBUTEN - UNII:IW71N46B4Y) 		CEFTIBUTEN180 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)1 g in 5 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BENZOATE(UNII: OJ245FE5EU)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE ((off-white to cream)) Score
Shape FREEFORM ((powder)) Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:44183-180-301 in 1 CARTON 01/10/2013
130 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:44183-180-021 in 1 CARTON 01/10/2013
260 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA050686 10/01/2013 12/31/2017

PRINCIPAL DISPLAY PANEL

NDC 44183-400-22

Ceftibuten
Capsules

400 mg

For Oral Administration

Rx only
20 Capsules

MACOVEN
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 400 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 44183-180-02

Ceftibuten Oral
Suspension

180
mg per 5 mL

60 mL (when reconstituted)

Rx only

MACOVEN
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton