Ibuprofen Immediate Release Tablets

Name: Ibuprofen Immediate Release Tablets

Package label.principal display panel





IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:57910-300
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  
CELLULOSE, MICROCRYSTALLINE  
STARCH, PREGELATINIZED CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TALC  
MAGNESIUM STEARATE  
LACTOSE MONOHYDRATE  
HYPROMELLOSES  
POLYETHYLENE GLYCOL 4000  
SODIUM CITRATE  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape ROUND (round shaped) Size 13mm
Flavor Imprint Code IBU;400
Contains     
Packaging
# Item Code Package Description
1 NDC:57910-300-01 100 TABLET in 1 BOTTLE
2 NDC:57910-300-05 500 TABLET in 1 BOTTLE
3 NDC:57910-300-22 22000 TABLET in 1 BAG
4 NDC:57910-300-25 2500 TABLET in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 02/05/2009
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:57910-200
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  
CELLULOSE, MICROCRYSTALLINE  
STARCH, PREGELATINIZED CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TALC  
MAGNESIUM STEARATE  
LACTOSE MONOHYDRATE  
HYPROMELLOSES  
POLYETHYLENE GLYCOL 4000  
SODIUM CITRATE  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code IBU;600
Contains     
Packaging
# Item Code Package Description
1 NDC:57910-200-01 100 TABLET in 1 BOTTLE
2 NDC:57910-200-05 500 TABLET in 1 BOTTLE
3 NDC:57910-200-14 14000 TABLET in 1 BAG
4 NDC:57910-200-25 2500 TABLET in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 02/05/2009
IBUPROFEN  IMMEDIATE RELEASE
ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:57910-100
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  
CELLULOSE, MICROCRYSTALLINE  
STARCH, PREGELATINIZED CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TALC  
MAGNESIUM STEARATE  
LACTOSE MONOHYDRATE  
HYPROMELLOSES  
POLYETHYLENE GLYCOL 4000  
SODIUM CITRATE  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code IBU;800
Contains     
Packaging
# Item Code Package Description
1 NDC:57910-100-01 100 TABLET in 1 BOTTLE
2 NDC:57910-100-05 500 TABLET in 1 BOTTLE
3 NDC:57910-100-11 11000 TABLET in 1 BAG
4 NDC:57910-100-25 2500 TABLET in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078329 02/05/2009
Labeler - Shasun Pharmaceuticals Limited (650064850)
Registrant - Shasun Pharmaceuticals Limited (915786829)
Establishment
Name Address ID/FEI Operations
Shasun Pharmaceuticals Limited 915786829 MANUFACTURE(57910-100, 57910-200, 57910-300)
Revised: 12/2012   Shasun Pharmaceuticals Limited
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