IBUPROFEN- ibuprofen tablet, film coated 
UNIT DOSE SERVICES

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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

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500

HOW SUPPLIED

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side)

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IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50436-0323(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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, PREGELATINIZED 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:50436-0323-130 in 1 BOTTLE; Type 0: Not a Combination Product06/28/2023
2NDC:50436-0323-260 in 1 BOTTLE; Type 0: Not a Combination Product06/28/2023
3NDC:50436-0323-390 in 1 BOTTLE; Type 0: Not a Combination Product06/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
Labeler - UNIT DOSE SERVICES (831995316)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SERVICES831995316repack(50436-0323)

Revised: 6/2023
Document Id: 2940ae96-4d64-4431-a535-8bf0ee258f4d
Set id: 7cb00cc2-20af-428c-8290-9b5bf0aec68d
Version: 1
Effective Time: 20230628
 
UNIT DOSE SERVICES