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

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side)

•   Bottles of 20 NDC: 68788-7745-02
  Bottles of 28 NDC: 68788-7745-08
  Bottles of 30 NDC: 68788-7745-03
  Bottles of 50 NDC: 68788-7745-05
  Bottles of 60 NDC: 68788-7745-06
  Bottles of 90 NDC: 68788-7745-09
  Bottles of 100 NDC: 68788-7745-01

Repackaged by Preferred Pharmaceuticals, Inc.

400mg Ibuprofen

IBUPROFEN 
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68788-7745(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)
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	ROUND	Size	13mm
Flavor		Imprint Code	121
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-7745-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	07/02/2025
2	NDC: 68788-7745-8	28 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	07/02/2025
3	NDC: 68788-7745-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	07/02/2025
4	NDC: 68788-7745-5	50 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	07/02/2025
5	NDC: 68788-7745-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	07/02/2025
6	NDC: 68788-7745-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	07/02/2025
7	NDC: 68788-7745-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	07/02/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090796	07/01/2020	07/02/2025

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals, Inc.		791119022	REPACK(68788-7745)

Revised: 7/2025

Document Id: 2032b7fb-2c25-42e1-b85d-94babfd7273e

34391-3

Set id: 20fda75a-c560-428b-b9fd-c12e97df4a74

Version: 6

Effective Time: 20250702