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

800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side)

Bottles of 4, 6, 9, 10, 12, 15, 18, 20, 21, 24, 28, 30, 40, 60, 90, 100, 180, 270 and 500.

800 mg label

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43063-858(NDC:49483-604)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	800 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	CAPSULE	Size	19mm
Flavor		Imprint Code	123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43063-858-04	4 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/22/2018
2	NDC: 43063-858-06	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2019
3	NDC: 43063-858-09	9 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/20/2019
4	NDC: 43063-858-10	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/06/2018
5	NDC: 43063-858-12	12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2018
6	NDC: 43063-858-15	15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2018
7	NDC: 43063-858-18	18 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2018
8	NDC: 43063-858-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/21/2018
9	NDC: 43063-858-21	21 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2018
10	NDC: 43063-858-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/08/2019
11	NDC: 43063-858-28	28 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/24/2019
12	NDC: 43063-858-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2018
13	NDC: 43063-858-40	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/03/2018
14	NDC: 43063-858-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2018
15	NDC: 43063-858-82	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/24/2020
16	NDC: 43063-858-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2018
17	NDC: 43063-858-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/03/2019
18	NDC: 43063-858-93	180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2018
19	NDC: 43063-858-94	270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/08/2018

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(43063-858)