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

----------

IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

HOW SUPPLIED

Product: 53002-3372

NDC: 53002-3372-1 15 TABLET, FILM COATED in a BOTTLE

NDC: 53002-3372-3 30 TABLET, FILM COATED in a BOTTLE

NDC: 53002-3372-5 50 TABLET, FILM COATED in a BOTTLE

Ibuprofen 400mg Tablets

Label Image
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53002-3372(NDC:49483-602)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN400 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
ShapeROUNDSize13mm
FlavorImprint Code 121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53002-3372-115 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2022
2NDC:53002-3372-330 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2022
3NDC:53002-3372-550 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2022
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(53002-3372) , REPACK(53002-3372)

Revised: 3/2022
Document Id: 69d85120-99fd-4d8e-a211-5f1b65a2cca7
Set id: 4f9fec6b-ffbc-48ea-a526-2f1f37de8bb7
Version: 1
Effective Time: 20220330
 
RPK Pharmaceuticals, Inc.