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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen(UNII: WK2XYI10QM)
(Ibuprofen - UNII:WK2XYI10QM) 		Ibuprofen400 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63739-442-1010 in 1 BOX, UNIT-DOSE 20/07/2009
110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:63739-442-0125 in 1 BOX, UNIT-DOSE 20/07/2009
230 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen(UNII: WK2XYI10QM)
(Ibuprofen - UNII:WK2XYI10QM) 		Ibuprofen600 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63739-443-1010 in 1 BOX, UNIT-DOSE 09/07/2009
110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:63739-443-0125 in 1 BOX, UNIT-DOSE 09/07/2009
230 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen(UNII: WK2XYI10QM)
(Ibuprofen - UNII:WK2XYI10QM) 		Ibuprofen800 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63739-444-1010 in 1 BOX, UNIT-DOSE 17/06/2009
110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:63739-444-0125 in 1 BOX, UNIT-DOSE 17/06/2009
230 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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