VALSARTAN AND HYDROCHLOROTHIAZIDE- valsartan and hydrochlorothiazide tablet, film coated 
Cadila Healthcare Limited

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VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg

NDC 70771-1485-0 in bottle of 1000 tablets

1000 tablets

Rx only

80 mg/ 12.5 mg

Valsartan and Hydrochlorothiazide Tablets USP, 160/12.5 mg

NDC 70771-1486-0 in bottle of 1000 tablets

1000 tablets

Rx only

160 mg/ 12.5 mg

Valsartan and Hydrochlorothiazide Tablets USP, 160/25 mg

NDC 70771-1487-0 in bottle of 1000 tablets

1000 tablets

Rx only

160 mg/ 25 mg

Valsartan and Hydrochlorothiazide Tablets USP, 320/12.5 mg

NDC 70771-1488-0 in bottle of 1000 tablets

1000 tablets

Rx only

320 mg/ 12.5 mg

Valsartan and Hydrochlorothiazide Tablets USP, 320/25 mg

NDC 70771-1489-0 in bottle of 1000 tablets

1000 tablets

Rx only

320 mg/ 25 mg
VALSARTAN AND HYDROCHLOROTHIAZIDE 
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1485
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN80 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (PINK) Scoreno score
ShapeOVAL (OVAL) Size12mm
FlavorImprint Code 279
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1485-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
2NDC:70771-1485-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
3NDC:70771-1485-410 in 1 CARTON02/12/2020
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20300002/12/2020
VALSARTAN AND HYDROCHLOROTHIAZIDE 
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1486
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN160 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
Product Characteristics
ColorBROWN (brownish red) Scoreno score
ShapeOVAL (OVAL) Size17mm
FlavorImprint Code 280
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1486-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
2NDC:70771-1486-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
3NDC:70771-1486-410 in 1 CARTON02/12/2020
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20300002/12/2020
VALSARTAN AND HYDROCHLOROTHIAZIDE 
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1487
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN160 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
Product Characteristics
ColorBROWN (BROWN) Scoreno score
ShapeOVAL (oval) Size17mm
FlavorImprint Code 282
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1487-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
2NDC:70771-1487-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
3NDC:70771-1487-410 in 1 CARTON02/12/2020
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20300002/12/2020
VALSARTAN AND HYDROCHLOROTHIAZIDE 
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1488
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN320 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (pink) Scoreno score
ShapeOVAL (oval) Size21mm
FlavorImprint Code 281
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1488-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
2NDC:70771-1488-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
3NDC:70771-1488-410 in 1 CARTON02/12/2020
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20300002/12/2020
VALSARTAN AND HYDROCHLOROTHIAZIDE 
valsartan and hydrochlorothiazide tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1489
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN320 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (BROWN) Scoreno score
ShapeOVAL (OVAL) Size21mm
FlavorImprint Code 283
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1489-990 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
2NDC:70771-1489-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2020
3NDC:70771-1489-410 in 1 CARTON02/12/2020
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20300002/12/2020
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1485, 70771-1486, 70771-1487, 70771-1488, 70771-1489) , MANUFACTURE(70771-1485, 70771-1486, 70771-1487, 70771-1488, 70771-1489)

Revised: 9/2020
Document Id: 8f127bea-e6cf-456e-86c0-f09f8d6e0541
Set id: bd199010-1d85-4011-939c-4704ecfaba1f
Version: 3
Effective Time: 20200914
 
Cadila Healthcare Limited