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

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Glipizide and Metformin Hydrochloride Tablets, USP

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

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

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
GLIPIZIDE AND METFORMIN HYDROCHLORIDE 
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-659
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE2.5 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE250 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorPINK (PINK) Scoreno score
ShapeCAPSULE (CAPSULE) Size11mm
FlavorImprint Code ZE68
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-659-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
2NDC:65841-659-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
3NDC:65841-659-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
4NDC:65841-659-7710 in 1 CARTON05/05/2016
4NDC:65841-659-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07890505/05/2016
GLIPIZIDE AND METFORMIN HYDROCHLORIDE 
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-660
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE2.5 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size15mm
FlavorImprint Code ZE67
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-660-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
2NDC:65841-660-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
3NDC:65841-660-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
4NDC:65841-660-7710 in 1 CARTON05/05/2016
4NDC:65841-660-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07890505/05/2016
GLIPIZIDE AND METFORMIN HYDROCHLORIDE 
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-661
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE5 mg
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (PINK) Scoreno score
ShapeCAPSULE (CAPSULE) Size15mm
FlavorImprint Code ZE66
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-661-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
2NDC:65841-661-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
3NDC:65841-661-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
4NDC:65841-661-7710 in 1 CARTON05/05/2016
4NDC:65841-661-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07890505/05/2016
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-659, 65841-660, 65841-661) , MANUFACTURE(65841-659, 65841-660, 65841-661)

Revised: 7/2020
Document Id: 4fb0919e-215f-4001-af20-6de44a767567
Set id: bd2e1c06-424b-4222-b723-90ffdcc3983c
Version: 5
Effective Time: 20200728
 
Cadila Healthcare Limited