IBUPROFEN- ibuprofen tablet, film coated 
DIRECT RX

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IBUPROFEN

[MEDGUIDE IBUPROFEN TABLETS]

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

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)

231

266

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72189-231-90

72189-231-60

72189-231-30

72189-266-15

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72189-266(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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72189-266-4040 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
2NDC:72189-266-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
3NDC:72189-266-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
4NDC:72189-266-71100 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
5NDC:72189-266-72120 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
6NDC:72189-266-6060 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
7NDC:72189-266-1515 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079609/16/2021
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72189-231(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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72189-231-2121 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2021
2NDC:72189-231-6060 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2021
3NDC:72189-231-9090 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2021
4NDC:72189-231-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079606/04/2021
Labeler - DIRECT RX (079254320)
Registrant - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(72189-231, 72189-266)

Revised: 7/2023
Document Id: ffbfd97f-39d7-c26f-e053-6294a90abc5a
Set id: c3f30813-0848-6e8a-e053-2995a90a3dea
Version: 10
Effective Time: 20230705
 
DIRECT RX