IBUPROFEN- ibuprofen tablet, film coated 
Bryant Ranch Prepack

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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

HOW SUPPLIED

Product: 71335-1396

NDC: 71335-1396-0 84 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1396-1 20 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1396-2 15 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1396-3 40 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1396-4 21 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1396-5 30 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1396-6 90 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1396-7 100 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1396-8 120 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1396-9 60 TABLET, FILM COATED in a BOTTLE

Product: 71335-1503

NDC: 71335-1503-0 21 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1503-1 20 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1503-2 15 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1503-3 30 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1503-4 40 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1503-5 60 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1503-6 90 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1503-7 120 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1503-8 50 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1503-9 100 TABLET, FILM COATED in a BOTTLE

Product: 71335-1517

NDC: 71335-1517-1 20 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1517-2 30 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1517-3 40 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1517-4 60 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1517-5 90 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1517-6 120 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1517-7 100 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1517-8 21 TABLET, FILM COATED in a BOTTLE

NDC: 71335-1517-9 15 TABLET, FILM COATED in a BOTTLE

Ibuprofen 800mg Tablet

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Ibuprofen 600mg Tablet

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Ibuprofen 400mg Tablet

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IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-1396(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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
STARCH, 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:71335-1396-084 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
2NDC:71335-1396-120 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
3NDC:71335-1396-215 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
4NDC:71335-1396-340 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
5NDC:71335-1396-421 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
6NDC:71335-1396-530 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
7NDC:71335-1396-690 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
8NDC:71335-1396-7100 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
9NDC:71335-1396-8120 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
10NDC:71335-1396-960 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-1503(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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
STARCH, 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:71335-1503-021 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
2NDC:71335-1503-120 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
3NDC:71335-1503-215 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
4NDC:71335-1503-330 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
5NDC:71335-1503-440 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
6NDC:71335-1503-560 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
7NDC:71335-1503-690 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
8NDC:71335-1503-7120 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
9NDC:71335-1503-850 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
10NDC:71335-1503-9100 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-1517(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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
STARCH, 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:71335-1517-120 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
2NDC:71335-1517-230 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
3NDC:71335-1517-340 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
4NDC:71335-1517-460 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
5NDC:71335-1517-590 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
6NDC:71335-1517-6120 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
7NDC:71335-1517-7100 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
8NDC:71335-1517-821 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
9NDC:71335-1517-915 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09079612/30/2015
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1517, 71335-1396, 71335-1503) , RELABEL(71335-1396, 71335-1503, 71335-1517)

Revised: 5/2020
Document Id: 840d6421-5e3e-4933-84fb-e5676439b9a0
Set id: 6d189e86-4c36-43f5-b406-a342458d4155
Version: 4
Effective Time: 20200527
 
Bryant Ranch Prepack