CANDESARTAN CILEXETIL- candesartan cilexetil tablet 
Cadila Healthcare Limited

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CANDESARTAN CILEXETIL TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1204-5

Candesartan Cilexetil Tablets USP, 4 mg

Rx Only

500 tablets

labels

NDC 70771-1205-5

Candesartan Cilexetil Tablets USP, 8 mg

Rx Only

500 tablets

labels

NDC 70771-1206-5

Candesartan Cilexetil Tablets USP, 16 mg

Rx Only

500 tablets

labels

NDC 70771-1207-5

Candesartan Cilexetil Tablets USP, 32 mg

Rx Only

500 tablets

labels
CANDESARTAN CILEXETIL 
candesartan cilexetil tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL4 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINK (LIGHT PINK) Score2 pieces
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZE;58
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1204-330 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
2NDC:70771-1204-990 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
3NDC:70771-1204-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09139002/22/2018
CANDESARTAN CILEXETIL 
candesartan cilexetil tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1205
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL8 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINK (PINK) Score2 pieces
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZE;59
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1205-330 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
2NDC:70771-1205-990 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
3NDC:70771-1205-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09139002/22/2018
CANDESARTAN CILEXETIL 
candesartan cilexetil tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL16 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE) Score2 pieces
ShapeROUND (ROUND) Size7mm
FlavorImprint Code ZE;60
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1206-330 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
2NDC:70771-1206-990 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
3NDC:70771-1206-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
4NDC:70771-1206-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
5NDC:70771-1206-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09139002/22/2018
CANDESARTAN CILEXETIL 
candesartan cilexetil tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL32 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size9mm
FlavorImprint Code ZE;61
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1207-330 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
2NDC:70771-1207-990 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
3NDC:70771-1207-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
4NDC:70771-1207-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
5NDC:70771-1207-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09139002/22/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1204, 70771-1205, 70771-1206, 70771-1207) , MANUFACTURE(70771-1204, 70771-1205, 70771-1206, 70771-1207)

Revised: 8/2020
Document Id: d8d42350-dc56-4c38-a661-0d0dc0f3c087
Set id: 26df3269-3682-4ce0-be81-8c029254b5a8
Version: 3
Effective Time: 20200814
 
Cadila Healthcare Limited