UMAN PRESCRIPTION DRUG NDC Product Code (Source) 23155-116
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE(GLIPIZIDE) GLIPIZIDE 2.5mg
METFORMIN HYDROCHLORIDE(METFORMIN) METFORMIN HYDROCHLORIDE 500mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
POVIDONE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
PROPYLENE GLYCOL
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code U785
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 23155-116-01 100TABLETIn1BOTTLE None
2 23155-116-10 1000TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078728 06/29/2010
GLIPIZIDE AND METFORMIN HCL
glipizide and metformin hcl tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 23155-117
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE(GLIPIZIDE) GLIPIZIDE 5mg
METFORMIN HYDROCHLORIDE(METFORMIN) METFORMIN HYDROCHLORIDE 500mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
POVIDONE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
PROPYLENE GLYCOL
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code U786
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 23155-117-01 100TABLETIn1BOTTLE None
2 23155-117-10 1000TABLETIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078728 06/29/2010
Labeler -Heritage Pharmaceuticals Inc.(780779901)