IRBESARTAN- irbesartan tablet 
Cadila Healthcare Limited

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IRBESARTAN TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1159-0 in bottles of 1000 tablets

 

Irbesartan Tablets USP, 75 mg

 

1000 Tablets

 

Rx Only

Irbesartan Tablets, USP - 75 mg

NDC 70771-1160-0 in bottles of 1000 tablets

 

Irbesartan Tablets USP, 150 mg

 

1000 Tablets

 

Rx Only

Irbsertan Tablets USP, 150 mg

NDC 70771-1161-0 in bottles of 1000 tablets

 

Irbesartan Tablets USP, 300 mg

 

1000 Tablets

 

Rx Only

Irbesartan Tablets USP, 300 mg
IRBESARTAN 
irbesartan tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1159
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N) IRBESARTAN75 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size11mm
FlavorImprint Code ZE53
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1159-330 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
2NDC:70771-1159-990 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
3NDC:70771-1159-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
4NDC:70771-1159-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
5NDC:70771-1159-410 in 1 CARTON12/08/2017
5NDC:70771-1159-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921312/08/2017
IRBESARTAN 
irbesartan tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1160
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N) IRBESARTAN150 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size13mm
FlavorImprint Code ZE54
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1160-330 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
2NDC:70771-1160-990 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
3NDC:70771-1160-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
4NDC:70771-1160-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
5NDC:70771-1160-410 in 1 CARTON12/08/2017
5NDC:70771-1160-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921312/08/2017
IRBESARTAN 
irbesartan tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N) IRBESARTAN300 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size17mm
FlavorImprint Code ZE55
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1161-330 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
2NDC:70771-1161-990 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
3NDC:70771-1161-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
4NDC:70771-1161-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
5NDC:70771-1161-410 in 1 CARTON12/08/2017
5NDC:70771-1161-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921312/08/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1159, 70771-1160, 70771-1161) , MANUFACTURE(70771-1159, 70771-1160, 70771-1161)

Revised: 8/2020
Document Id: 96aa699e-e12d-4327-a51c-f9b38150d30d
Set id: 78881d04-6455-4539-b613-791855c99052
Version: 4
Effective Time: 20200831
 
Cadila Healthcare Limited