CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE - candesartan cilexetil and hydrochlorothiazide tablet 
Zydus Lifesciences Limited

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Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, for oral use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1325-0 in bottle of 1000 tablets

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg

Rx only

1000 tablets

Candesartan cilexetil and hydrochlorothiazide tablets

NDC 70771-1326-0 in bottle of 1000 tablets

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg

Rx only

1000 tablets

Candesartan cilexetil and hydrochlorothiazide tablets

NDC 70771-1327-0 in bottle of 1000 tablets

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg

Rx only

1000 tablets

Candesartan cilexetil and hydrochlorothiazide tablets
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 
candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL16 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
STARCH, CORN (UNII: O8232NY3SJ)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size10mm
FlavorImprint Code 19;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1325-330 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
2NDC:70771-1325-990 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
3NDC:70771-1325-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
4NDC:70771-1325-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
5NDC:70771-1325-410 in 1 CARTON04/14/2018
5NDC:70771-1325-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20346604/14/2018
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 
candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1326
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL32 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
STARCH, CORN (UNII: O8232NY3SJ)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size11mm
FlavorImprint Code 19;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1326-410 in 1 CARTON04/14/2018
1NDC:70771-1326-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70771-1326-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
3NDC:70771-1326-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
4NDC:70771-1326-990 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
5NDC:70771-1326-330 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20346604/14/2018
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 
candesartan cilexetil and hydrochlorothiazide tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1327
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CANDESARTAN CILEXETIL (UNII: R85M2X0D68) (CANDESARTAN - UNII:S8Q36MD2XX) CANDESARTAN CILEXETIL32 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
STARCH, CORN (UNII: O8232NY3SJ)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeOVAL (OVAL) Size11mm
FlavorImprint Code 41;6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1327-330 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
2NDC:70771-1327-990 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
3NDC:70771-1327-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
4NDC:70771-1327-01000 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2018
5NDC:70771-1327-410 in 1 CARTON04/14/2018
5NDC:70771-1327-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20346604/14/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1325, 70771-1326, 70771-1327) , MANUFACTURE(70771-1325, 70771-1326, 70771-1327)

Revised: 10/2022
Document Id: d579d9c3-cadd-4e79-bc27-ca62ac186781
Set id: cb328bc1-5738-4620-b2b3-442e98388a86
Version: 4
Effective Time: 20221013
 
Zydus Lifesciences Limited