Glipizide and Metformin Hydrochloride (Page 10 of 10)

PRINCIPAL DISPLAY PANELS

Image of 2.5 mg/250 mg Label
(click image for full-size original)

2.5 mg/250 mg — 100 Tablets Label Text

GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets

2.5 mg/250 mg*

PHARMACIST: PLEASE DISPENSE WITH

ATTACHED PATIENT INFORMATION LEAFLET

Rx only

Image of 2.5 mg/250 mg Label
(click image for full-size original)

2.5 mg/500 mg — 100 Tablets Label Text

GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets

2.5 mg/500 mg*

PHARMACIST: PLEASE DISPENSE WITH

ATTACHED PATIENT INFORMATION

LEAFLET

Rx only

Image of 2.5 mg/500 mg Label
(click image for full-size original)

5 mg/500 mg — 100 Tablets Label Text

GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets

5 mg/500 mg*

PHARMACIST: PLEASE DISPENSE WITH

ATTACHED PATIENT INFORMATION

LEAFLET

Rx only

Image of 5 mg/500mg Label
(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:54868-0795(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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
POVIDONE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color pink Score no score
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code 93;7455
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0795-0 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077270 04/30/2007
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5188(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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
POVIDONE
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL (capsule-shaped) Size 17mm
Flavor Imprint Code 93;7456
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5188-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5188-1 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:54868-5188-2 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077270 11/14/2005
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5467(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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYVINYL ALCOHOL
POVIDONE
STARCH, CORN
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color pink Score no score
Shape OVAL (capsule-shaped) Size 17mm
Flavor Imprint Code 93;7457
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5467-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5467-1 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:54868-5467-2 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077270 11/14/2005
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 03/2010 Physicians Total Care, Inc.

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