ase
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13913-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
Product Characteristics
Color blue (blue) Score no score
Shape OVAL (OVAL) Size 18mm
Flavor Imprint Code GMZ;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13913-002-13 100 TABLET, FILM COATED, EXTENDED RELEASE ( TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021748 08/01/2006
GLUMETZA
metformin hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13913-003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 1000mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
POLYVINYL ALCOHOL
CROSPOVIDONE
GLYCERYL BEHENATE
HYPROMELLOSES
TALC
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
POLYSORBATE 80
Product Characteristics
Color white (white) Score no score
Shape OVAL (OVAL) Size 20mm
Flavor Imprint Code M1000
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13913-003-16 90 TABLET, FILM COATED, EXTENDED RELEASE ( TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021748 06/17/2008
Labeler -Depomed, Inc. (937562890)
Establishment
Name Address ID/FEI Operations
Patheon Puerto Rico, Inc. 174050377 manufacture
Establishment
Name Address ID/FEI Operations
Valeant Pharmaceuticals International, Inc 253292734 manufacture
