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: 53002-3011

NDC: 53002-3011-1 10 TABLET, FILM COATED in a BOTTLE

NDC: 53002-3011-2 15 TABLET, FILM COATED in a BOTTLE

NDC: 53002-3011-4 30 TABLET, FILM COATED in a BOTTLE

NDC: 53002-3011-5 50 TABLET, FILM COATED in a BOTTLE

Ibuprofen 600mg Tablets, USP

Label Image
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53002-3011(NDC:49483-603)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN600 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
ShapeCAPSULESize18mm
FlavorImprint Code 122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53002-3011-430 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
2NDC:53002-3011-110 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
3NDC:53002-3011-550 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
4NDC:53002-3011-215 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
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(53002-3011) , REPACK(53002-3011)

Revised: 6/2023
Document Id: e02a2964-1671-4427-84ac-80adf6c0e05c
Set id: 2913f3f3-6998-4f24-ae35-2ba834f7ddd2
Version: 3
Effective Time: 20230607
 
RPK Pharmaceuticals, Inc.