IBUPROFEN tablet, film coated

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Prescription medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

HOW SUPPLIED

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 6, 10, 20, 30, 40, 90 and 500

400mg label

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43063-872(NDC:49483-602)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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	ROUND	Size	13mm
Flavor		Imprint Code	121
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43063-872-06	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/25/2019
2	NDC: 43063-872-10	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/29/2019
3	NDC: 43063-872-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/07/2018
4	NDC: 43063-872-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/07/2018
5	NDC: 43063-872-40	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/07/2018
6	NDC: 43063-872-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2019
7	NDC: 43063-872-82	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090796	12/30/2015

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack(43063-872)