IBUPROFEN- ibuprofen tablet, film coated 
Northwind Pharmaceuticals

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IBUPROFEN 400 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 30.

NDC 5655-759-52

Principal Display Panel

NDC: 51655-759-52

Label

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-759(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)  
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
ShapeROUNDSize13mm
FlavorImprint Code 121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51655-759-5230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079608/05/2021
Labeler - Northwind Pharmaceuticals (036986393)
Registrant - Northwind Pharmaceuticals (036986393)
Establishment
NameAddressID/FEIBusiness Operations
Northwind Pharmaceuticals036986393repack(51655-759)

Revised: 1/2023
Document Id: da6c3f54-e2b2-22d2-e053-2995a90a27c1
Set id: da6c72ad-009f-3d7f-e053-2995a90a68e9
Version: 1
Effective Time: 20230101
 
Northwind Pharmaceuticals