Prescription Drug Information: Glipizide and Metformin Hydrochloride (Page 7 of 7)

Package/Label Display Panel

NDC 0093-7455-01
Glipizide and Metformin Hydrochloride Tablets, USP
2.5 mg/250 mg
PHARMACIST: PLEASE DISPENSE WITH ACCOMPANYING PATIENT INFORMATION LEAFLET
Rx only100 TABLETS

1
(click image for full-size original)

Package/Label Display Panel

NDC 0093-7456-01
Glipizide and Metformin Hydrochloride Tablets, USP
2.5 mg/500 mg
PHARMACIST: PLEASE DISPENSE WITH ACCOMPANYING PATIENT INFORMATION LEAFLET
Rx only100 TABLETS

1
(click image for full-size original)

Package/Label Display Panel

NDC 0093-7457-01
Glipizide and Metformin Hydrochloride Tablets, USP
5 mg/500 mg
PHARMACIST: PLEASE DISPENSE WITH ACCOMPANYING PATIENT INFORMATION LEAFLET
Rx only100 TABLETS

1
(click image for full-size original)
GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7455
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE (GLIPIZIDE) GLIPIZIDE 2.5 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE K30
POVIDONE K90
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color pink Score no score
Shape OVAL (modified capsule-shaped) Size 14mm
Flavor Imprint Code 93;7455
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-7455-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077270 10/28/2005
GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7456
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE (GLIPIZIDE) GLIPIZIDE 2.5 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE K30
POVIDONE K90
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL (modified capsule-shaped) Size 17mm
Flavor Imprint Code 93;7456
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-7456-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077270 10/28/2005
GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-7457
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLIPIZIDE (GLIPIZIDE) GLIPIZIDE 5 mg
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 4000
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE K30
POVIDONE K90
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color pink Score no score
Shape OVAL (modified capsule-shaped) Size 17mm
Flavor Imprint Code 93;7457
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-7457-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077270 10/28/2005
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2020 Teva Pharmaceuticals USA, Inc.

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