IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

IBUPROFEN by

Drug Labeling and Warnings

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

Drug Details [pdf]

IBUPROFEN- ibuprofen tablet, film coated 
Preferred Pharmaceuticals Inc.

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IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

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 14 NDC: 68788-7079-4

Repackaged By: Preferred Pharmaceuticals Inc.

800mg LABEL

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68788-7079(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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, 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: 68788-7079-4	14 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	07/13/2023
2	NDC: 68788-7079-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	07/13/2023
3	NDC: 68788-7079-7	21 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	07/13/2023
4	NDC: 68788-7079-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	07/13/2023
5	NDC: 68788-7079-5	50 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	07/13/2023
6	NDC: 68788-7079-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	07/13/2023
7	NDC: 68788-7079-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	07/13/2023
8	NDC: 68788-7079-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	07/13/2023
9	NDC: 68788-7079-8	120 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020	07/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090796	06/17/2020	07/13/2023

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	REPACK(68788-7079)

Revised: 7/2023

Document Id: d8b1b4f8-7e34-4f45-be18-d2430ebe934f

34391-3

Set id: f4b778cf-0741-46b3-ace9-7ac8d0695e31

Version: 4

Effective Time: 20230713