Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020682 12/18/1996 

GLYSET
miglitol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-5014
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
miglitol(miglitol) miglitol 100mg
 
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline 
magnesium stearate 
hypromelloses 
polyethylene glycol 
titanium dioxide 
polysorbate 80 
 
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor  Imprint Code GLYSET;100 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 0009-5014-01 100TABLETIn1BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020682 12/18/1996 

Labeler -Pharmacia and Upjohn Company(829076566)
Establishment
Name Address ID/FEI Operations
Bayer Schering Pharma AG  312602409 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Bayer Schering Pharma AG  341081414 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company  829076566 REPACK