Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019949 01/29/1990 

DIFLUCAN 
fluconazole   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-3420
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fluconazole (fluconazole)  fluconazole 100 mg
 
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline  
anhydrous dibasic calcium phosphate  
povidone  
croscarmellose sodium  
FD&C Red No. 40  
aluminum oxide  
magnesium stearate  
 
Product Characteristics
Color PINK Score no score 
Shape TRAPEZOID Size 10mm
Flavor  Imprint Code DIFLUCAN;100;ROERIG 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0049-3420-30 30 TABLET In 1 BOTTLE None
2 0049-3420-41 100 TABLET In 1 BLISTER PACK None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019949 01/29/1990 

DIFLUCAN 
fluconazole   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-3500
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fluconazole (fluconazole)  fluconazole 150 mg
 
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline  
anhydrous dibasic calcium phosphate  
povidone  
croscarmellose sodium  
FD&C Red No. 40  
aluminum oxide  
magnesium stearate  
 
Product Characteristics
Color PINK Score no score 
Shape OVAL Size 12mm
Flavor  Imprint Code DIFLUCAN;150;ROERIG 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0049-3500-79 1 TABLET In 1 BLISTER PACK None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019949 01/29/1990 

DIFLUCAN 
fluconazole   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-3430
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fluconazole (fluconazole)  fluconazole 200 mg
 
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline  
anhydrous dibasic calcium phosphate  
povidone  
croscarmellose sodium  
FD&C Red No. 40