IBUPROFEN- ibuprofen tablet, film coated 
St. Mary's Medical Park Pharmacy

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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

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

Supplied as:

NDC 60760-604-09 BOTTLES OF 9

NDC 60760-604-20 BOTTLES OF 20

NDC 60760-604-30 BOTTLES OF 30

NDC 60760-604-60 BOTTLES OF 60

NDC 60760-604-90 BOTTLES OF 90

NDC 60760-604-00 BOTTLES OF 100

ibu

IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60760-604(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:60760-604-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2019
2NDC:60760-604-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2019
3NDC:60760-604-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2019
4NDC:60760-604-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
5NDC:60760-604-099 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/10/2020
6NDC:60760-604-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079610/16/2019
Labeler - St. Mary's Medical Park Pharmacy (063050751)
Establishment
NameAddressID/FEIBusiness Operations
St. Mary's Medical Park Pharmacy063050751relabel(60760-604) , repack(60760-604)

Revised: 7/2020
Document Id: a9f31e25-9560-5012-e053-2a95a90a52c0
Set id: 950c3ca7-4481-976f-e053-2995a90ad51e
Version: 4
Effective Time: 20200708
 
St. Mary's Medical Park Pharmacy