PIOGLITAZONE- pioglitazone tablet 
Cadila Healthcare Limited

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PIOGLITAZONE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1021-3 in bottle of 30 tablets

Pioglitazone Tablets USP, 15 mg

Rx only

30 tablets

Pioglitazone Tablets USP, 15 mg

NDC 70771-1022-3 in bottle of 30 tablets

Pioglitazone Tablets USP, 30 mg

Rx only

30 tablets

Pioglitazone Tablets USP, 30 mg

NDC 70771-1023-3 in bottle of 30 tablets

Pioglitazone Tablets USP, 45 mg

Rx only

30 tablets

Pioglitazone Tablets USP, 45 mg
PIOGLITAZONE 
pioglitazone tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S) PIOGLITAZONE15 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
Product Characteristics
ColorWHITE (off-white to cream white) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 306
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1021-330 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
2NDC:70771-1021-990 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
3NDC:70771-1021-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
4NDC:70771-1021-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
5NDC:70771-1021-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
6NDC:70771-1021-410 in 1 CARTON11/16/2016
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20245611/16/2016
PIOGLITAZONE 
pioglitazone tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S) PIOGLITAZONE30 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
Product Characteristics
ColorWHITE (off-white to cream white) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 307
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1022-330 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
2NDC:70771-1022-990 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
3NDC:70771-1022-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
4NDC:70771-1022-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
5NDC:70771-1022-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
6NDC:70771-1022-410 in 1 CARTON11/16/2016
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20245611/16/2016
PIOGLITAZONE 
pioglitazone tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S) PIOGLITAZONE45 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
Product Characteristics
ColorWHITE (off-white to cream white) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 308
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1023-330 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
2NDC:70771-1023-990 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
3NDC:70771-1023-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
4NDC:70771-1023-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
5NDC:70771-1023-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2016
6NDC:70771-1023-410 in 1 CARTON11/16/2016
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20245611/16/2016
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1021, 70771-1022, 70771-1023) , MANUFACTURE(70771-1021, 70771-1022, 70771-1023)

Revised: 9/2020
Document Id: faa0e894-faa1-4c61-bf24-09f67005f535
Set id: 008c5659-7430-4a9b-927f-5cb97763616a
Version: 6
Effective Time: 20200908
 
Cadila Healthcare Limited