IBUPROFEN- ibuprofen tablet, film coated 
PD-Rx Pharmaceuticals, Inc.

----------

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) B

NDC 43063-867-10 Bottles of 10

NDC 43063-867-30 Bottles of 30

NDC 43063-867-60 Bottles of 60

NDC 43063-867-01 Bottles of 100

600 mg

image

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43063-867(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:43063-867-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2018
2NDC:43063-867-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2018
3NDC:43063-867-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2018
4NDC:43063-867-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-867)

Revised: 10/2023
Document Id: 08f0140d-d084-19fa-e063-6394a90a0e61
Set id: 701ee488-c57f-a82c-e053-2991aa0af403
Version: 21
Effective Time: 20231030
 
PD-Rx Pharmaceuticals, Inc.