IBUPROFEN- ibuprofen tablet, film coated 
Northwind Pharmaceuticals

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IBUPROFEN 600 MG TABLETS

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

MEDGUIDE IBUPROFEN TABLETS

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 20 NDC: 51655-474-20, 30 NDC: 51655-474-52, 40 NDC: 51655-474-51, 60 NDC: 51655-474-25, and 90 NDC: 51655-474-90.

600 mg 30 count label

NDC: 51655-474-52

Label

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-474(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)  
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
ShapeCAPSULESize18mm
FlavorImprint Code 122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51655-474-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
2NDC:51655-474-2560 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2020
3NDC:51655-474-5140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2021
4NDC:51655-474-5230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2021
5NDC:51655-474-2690 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079611/13/2020
Labeler - Northwind Pharmaceuticals (036986393)
Registrant - Northwind Pharmaceuticals (036986393)
Establishment
NameAddressID/FEIBusiness Operations
Northwind Pharmaceuticals036986393repack(51655-474)

Revised: 1/2023
Document Id: dac06b73-4572-2e8b-e053-2995a90a751e
Set id: dac07d8f-6b6f-20ab-e053-2a95a90af3ba
Version: 1
Effective Time: 20230101
 
Northwind Pharmaceuticals