IBUPROFEN- ibuprofen tablet, film coated 
RPK Pharmaceuticals, Inc.

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IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

HOW SUPPLIED

Product: 53002-3981

NDC: 53002-3981-1 10 TABLET, FILM COATED in a BOTTLE

NDC: 53002-3981-2 15 TABLET, FILM COATED in a BOTTLE

NDC: 53002-3981-3 30 TABLET, FILM COATED in a BOTTLE

NDC: 53002-3981-5 50 TABLET, FILM COATED in a BOTTLE

IBUPROFEN TABLET, FILM COATED

Label Image
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53002-3981(NDC:49483-604)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN800 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53002-3981-215 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
2NDC:53002-3981-330 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
3NDC:53002-3981-550 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
4NDC:53002-3981-110 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
Labeler - RPK Pharmaceuticals, Inc. (147096275)
Establishment
NameAddressID/FEIBusiness Operations
RPK Pharmaceuticals, Inc.147096275RELABEL(53002-3981) , REPACK(53002-3981)

Revised: 7/2023
Document Id: 66fd620c-5d48-4f17-a94c-c74a7871db3a
Set id: ca1e0d03-cbb3-4899-b196-0eee09c511a2
Version: 2
Effective Time: 20230706
 
RPK Pharmaceuticals, Inc.