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Ibuprofen

Pronunciation

Dosage Form: tablet, film coated

How is Ibuprofen Supplied

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

How is Ibuprofen 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 30, 50, 100 & 500

800mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '123' on one side and plain on the other side) Bottles of 30, 50, 100 & 500

400mg Ibuprofen Package Label 

600mg Ibuprofen Package Label

800mg Ibuprofen Package Label

Ibuprofen 
Ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49483-602
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (Ibuprofen) Ibuprofen 400 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
STARCH, PREGELATINIZED CORN  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score no score
Shape ROUND Size 13mm
Flavor Imprint Code 121
Contains         
Packaging
# Item Code Package Description
1 NDC:49483-602-01 100 TABLET, FILM COATED in 1 BOTTLE
2 NDC:49483-602-50 500 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 12/30/2015
Ibuprofen 
Ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49483-603
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (Ibuprofen) Ibuprofen 600 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
STARCH, PREGELATINIZED CORN  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score no score
Shape capsule Size 18mm
Flavor Imprint Code 122
Contains         
Packaging
# Item Code Package Description
1 NDC:49483-603-03 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:49483-603-05 50 TABLET, FILM COATED in 1 BOTTLE
3 NDC:49483-603-01 100 TABLET, FILM COATED in 1 BOTTLE
4 NDC:49483-603-50 500 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 12/30/2015
Ibuprofen 
Ibuprofen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49483-604
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (Ibuprofen) Ibuprofen 800 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
STARCH, PREGELATINIZED CORN  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score no score
Shape capsule Size 19mm
Flavor Imprint Code 123
Contains         
Packaging
# Item Code Package Description
1 NDC:49483-604-03 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:49483-604-05 50 TABLET, FILM COATED in 1 BOTTLE
3 NDC:49483-604-01 100 TABLET, FILM COATED in 1 BOTTLE
4 NDC:49483-604-50 500 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 12/30/2015
Labeler - TIME CAP LABORATORIES, INC (037052099)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 manufacture(49483-602, 49483-603, 49483-604)
Revised: 12/2015
 
TIME CAP LABORATORIES, INC



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