Glipizide and Metformin Hydrochloride

GLIPIZIDE AND METFORMIN HYDROCHLORIDE- glipizide and metformin hydrochloride tablet, film coated
GLIPIZIDE AND METFORMIN HYDROCHLORIDE- glipizide and metformin hydrochloride tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-659-01 in bottle of 100 tablets

Glipizide and Metformin Hydrochloride Tablets USP, 2.5 mg/250 mg

Rx only

100 tablets

Glipizide and Metformin HCL Tablets
(click image for full-size original)

NDC 65841-660-01 in bottle of 100 tablets

Glipizide and Metformin Hydrochloride Tablets USP, 2.5 mg/500 mg

Rx only

100 tablets

Glipizide and metformin HCL Tablets
(click image for full-size original)

NDC 65841-661-01 in bottle of 100 tablets

Glipizide and Metformin Hydrochloride Tablets USP, 5 mg/500 mg

Rx only

100 tablets

Glipizide and metformin HCL Tablets
(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:65841-659
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
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK (PINK) Score no score
Shape CAPSULE (CAPSULE) Size 11mm
Flavor Imprint Code ZE68
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-659-16 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-659-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-659-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-659-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-659-30)
4 NDC:65841-659-30 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-659-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078905 05/05/2016
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-660
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
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
POLYSORBATE 80
Product Characteristics
Color WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 15mm
Flavor Imprint Code ZE67
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-660-16 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-660-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-660-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-660-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-660-30)
4 NDC:65841-660-30 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-660-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078905 05/05/2016
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-661
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color PINK (PINK) Score no score
Shape CAPSULE (CAPSULE) Size 15mm
Flavor Imprint Code ZE66
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-661-16 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-661-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-661-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-661-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (65841-661-30)
4 NDC:65841-661-30 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-661-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078905 05/05/2016
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-659), ANALYSIS (65841-660), ANALYSIS (65841-661), MANUFACTURE (65841-659), MANUFACTURE (65841-660), MANUFACTURE (65841-661)

Revised: 07/2020 Cadila Healthcare Limited

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