Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020329 04/26/1994 

GLUCOTROL XL
glipizide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-1550
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glipizide(glipizide) glipizide 5mg
 
Inactive Ingredients
Ingredient Name Strength
polyethylene glycol 
hypromelloses 
magnesium stearate 
sodium chloride 
ferric oxide red 
cellulose acetate 
 
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex)  Size 8mm
Flavor  Imprint Code GLUCOTROL;XL;5 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 0049-1550-66 100TABLETIn1BOTTLE None
2 0049-1550-73 500TABLETIn1BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020329 04/26/1994 

GLUCOTROL XL
glipizide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-1560
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glipizide(glipizide) glipizide 10mg
 
Inactive Ingredients
Ingredient Name Strength
polyethylene glycol 
hypromelloses 
magnesium stearate 
sodium chloride 
ferric oxide red 
cellulose acetate 
 
Product Characteristics
Color WHITE Score no score
Shape ROUND (biconvex)  Size 10mm
Flavor  Imprint Code GLUCOTROL;XL;10 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 0049-1560-66 100TABLETIn1BOTTLE None
2 0049-1560-73 500TABLETIn1BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020329 04/10/1999 

Labeler -Roerig(829076996)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC  829084545 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Microchem S.r.l.  445019862 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Antibioticos S.P.A.  433371143 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Urquima S.A  460940854 API MANUFACTURE