GLIPIZIDE- glipizide tablet, extended release 
Zydus Lifesciences Limited

----------

Glipizide Extended-Release Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1098-3  in bottle of 30 tablets

Glipizide Tablets, 2.5 mg

Rx only

30 tablets

ZYDUS

Glipizide ER Tablets

NDC 70771-1099-3 in bottle of 30 tablets

Glipizide Tablets, 5 mg

Rx only

30 tablets

ZYDUS

Glipizide ER Tablets

NDC 70771-1100-3 in bottle of 30 tablets

Glipizide Tablets, 10 mg

Rx only

30 tablets

ZYDUS

Glipizide ER Tablets
GLIPIZIDE 
glipizide tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1098
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE2.5 mg
Inactive Ingredients
Ingredient NameStrength
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (Yellow) Scoreno score
ShapeROUND (Round) Size6mm
FlavorImprint Code 2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1098-330 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
2NDC:70771-1098-660 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
3NDC:70771-1098-990 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
4NDC:70771-1098-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
5NDC:70771-1098-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
6NDC:70771-1098-01000 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
7NDC:70771-1098-410 in 1 CARTON07/25/2018
7NDC:70771-1098-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20349907/25/2018
GLIPIZIDE 
glipizide tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1099
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGE (Orange) Scoreno score
ShapeROUND (Round) Size6mm
FlavorImprint Code 3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1099-330 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
2NDC:70771-1099-660 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
3NDC:70771-1099-990 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
4NDC:70771-1099-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
5NDC:70771-1099-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
6NDC:70771-1099-01000 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
7NDC:70771-1099-410 in 1 CARTON07/25/2018
7NDC:70771-1099-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20349907/25/2018
GLIPIZIDE 
glipizide tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeROUND (Round) Size6mm
FlavorImprint Code 4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1100-330 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
2NDC:70771-1100-660 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
3NDC:70771-1100-990 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
4NDC:70771-1100-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
5NDC:70771-1100-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
6NDC:70771-1100-01000 in 1 BOTTLE; Type 0: Not a Combination Product07/25/2018
7NDC:70771-1100-410 in 1 CARTON07/25/2018
7NDC:70771-1100-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20349907/25/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1098, 70771-1099, 70771-1100) , MANUFACTURE(70771-1098, 70771-1099, 70771-1100)

Revised: 11/2024
Document Id: f7fb046c-a4bf-492d-a485-223e3c8163fd
Set id: ff98778f-7c76-4f41-8c6a-d335c74b3a1f
Version: 6
Effective Time: 20241130
 
Zydus Lifesciences Limited