NDC 63739-443-01
API & Excipient Details

Ibuprofen marketed by McKesson Packaging Services a business unit of McKesson Corporation under NDC Code 63739-443-01

NDC Code(s) : 63739-442-10, 63739-442-01, 63739-443-10, 63739-443-01, 63739-444-10, 63739-444-01
Packager : McKesson Packaging Services a business unit of McKesson Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IBUIbuprofen TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63739-442(NDC:55111-682)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ibuprofen(UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)	Ibuprofen	400 mg

Ingredient Name	Strength
Inactive Ingredients
carnauba wax(UNII: R12CBM0EIZ)
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
magnesium stearate(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
polydextrose(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
polysorbate 80(UNII: 6OZP39ZG8H)
titanium dioxide(UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8 mm
Flavor		Imprint Code	4I
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63739-442-10	10 in 1 BOX, UNIT-DOSE	20/07/2009
1		10 in 1 BLISTER PACK Type 0: Not a Combination Product
2	NDC:63739-442-01	25 in 1 BOX, UNIT-DOSE	20/07/2009
2		30 in 1 BLISTER PACK Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075682	07/20/2009	07/31/2015

IBUIbuprofen TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63739-443(NDC:55111-683)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ibuprofen(UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)	Ibuprofen	600 mg

Ingredient Name	Strength
Inactive Ingredients
carnauba wax(UNII: R12CBM0EIZ)
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
magnesium stearate(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
polydextrose(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
polysorbate 80(UNII: 6OZP39ZG8H)
titanium dioxide(UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	9 mm
Flavor		Imprint Code	6I
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63739-443-10	10 in 1 BOX, UNIT-DOSE	09/07/2009
1		10 in 1 BLISTER PACK Type 0: Not a Combination Product
2	NDC:63739-443-01	25 in 1 BOX, UNIT-DOSE	09/07/2009
2		30 in 1 BLISTER PACK Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075682	07/09/2009	06/30/2015

IBUIbuprofen TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63739-444(NDC:55111-684)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ibuprofen(UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM)	Ibuprofen	800 mg

Ingredient Name	Strength
Inactive Ingredients
carnauba wax(UNII: R12CBM0EIZ)
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
magnesium stearate(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
polydextrose(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
polysorbate 80(UNII: 6OZP39ZG8H)
titanium dioxide(UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	9 mm
Flavor		Imprint Code	8I
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63739-444-10	10 in 1 BOX, UNIT-DOSE	17/06/2009
1		10 in 1 BLISTER PACK Type 0: Not a Combination Product
2	NDC:63739-444-01	25 in 1 BOX, UNIT-DOSE	17/06/2009
2		30 in 1 BLISTER PACK Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075682	06/17/2009	08/31/2015

PRINCIPAL DISPLAY PANEL

Ibuprofen Tablets 400mg Label

PRINCIPAL DISPLAY PANEL

Ibuprofen Tablets 600mg Label

PRINCIPAL DISPLAY PANEL

Ibuprofen Tablets 800mg Label