ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

HOW SUPPLIED

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

PDP 600 mg

IBUPROFEN
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:45865-117(NDC:49483-603)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	122
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45865-117-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC:45865-117-21	21 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
3	NDC:45865-117-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
4	NDC:45865-117-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090796	07/01/2020

Labeler - Medsource Pharmaceuticals (833685915)

Name	Address	ID/FEI	Business Operations
Establishment
Medsource Pharmaceuticals		833685915	repack(45865-117)

IBUPROFEN 600 MG TABLETS

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

HOW SUPPLIED

PDP 600 mg