PROTOPIC 
tacrolimus   ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0469-5201
Route of Administration TOPICAL DEA Schedule    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS) TACROLIMUS 0.3 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL 
PARAFFIN 
PROPYLENE CARBONATE 
PETROLATUM 
WHITE WAX 
Product Characteristics
Color      Score    
Shape  Size 
Flavor  Imprint Code 
Contains    
Packaging
# NDC Package Description Multilevel Packaging
1 0469-5201-30 30 g In 1 TUBE None
2 0469-5201-60 60 g In 1 TUBE None
3 0469-5201-11 100 g In 1 TUBE None
4 0469-5201-02 2 g In 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050777 12/08/2000 
PROTOPIC 
tacrolimus   ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0469-5202
Route of Administration TOPICAL DEA Schedule    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TACROLIMUS (TACROLIMUS) TACROLIMUS 1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL 
PARAFFIN 
PROPYLENE CARBONATE 
PETROLATUM 
WHITE WAX 
Product Characteristics
Color      Score    
Shape  Size 
Flavor  Imprint Code 
Contains    
Packaging
# NDC Package Description Multilevel Packaging
1 0469-5202-30 30 g In 1 TUBE None
2 0469-5202-60 60 g In 1 TUBE None
3 0469-5202-11 100 g In 1 TUBE None
4 0469-5202-02 2 g In 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050777 12/08/2000 
Labeler - Astellas Pharma US, Inc. (605764828) Revised: 06/2009 Astellas Pharma US, Inc.
https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=16278