Valsartan and Hydrochlorothiazide

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

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

Valsartan and Hydrochlorothiazide Tablets USP, 160/12.5 mg

NDC 70771-1486-0 in bottle of 1000 tablets

1000 tablets

Rx only

Valsartan and Hydrochlorothiazide Tablets USP, 160/25 mg

NDC 70771-1487-0 in bottle of 1000 tablets

1000 tablets

Rx only

Valsartan and Hydrochlorothiazide Tablets USP, 320/12.5 mg

NDC 70771-1488-0 in bottle of 1000 tablets

1000 tablets

Rx only

Valsartan and Hydrochlorothiazide Tablets USP, 320/25 mg

NDC 70771-1489-0 in bottle of 1000 tablets

1000 tablets

Rx only

VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1485 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (VALSARTAN) VALSARTAN 80 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE TALC TITANIUM DIOXIDE

Product Characteristics Color PINK (PINK) Score no score Shape OVAL (OVAL) Size 12mm Flavor Imprint Code 279 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1485-9 90 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1485-0 1000 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1485-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1485-4)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203000 02/12/2020

VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1486 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (VALSARTAN) VALSARTAN 160 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CROSPOVIDONE FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL 4000

Product Characteristics Color BROWN (brownish red) Score no score Shape OVAL (OVAL) Size 17mm Flavor Imprint Code 280 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1486-9 90 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1486-0 1000 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1486-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1486-4)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203000 02/12/2020

VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1487 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (VALSARTAN) VALSARTAN 160 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TITANIUM DIOXIDE TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CROSPOVIDONE FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL 4000

Product Characteristics Color BROWN (BROWN) Score no score Shape OVAL (oval) Size 17mm Flavor Imprint Code 282 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1487-9 90 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1487-0 1000 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1487-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1487-4)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203000 02/12/2020

VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1488 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (VALSARTAN) VALSARTAN 320 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 4000 SILICON DIOXIDE TALC TITANIUM DIOXIDE

Product Characteristics Color PINK (pink) Score no score Shape OVAL (oval) Size 21mm Flavor Imprint Code 281 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1488-9 90 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1488-0 1000 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1488-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1488-4)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203000 02/12/2020

VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1489 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (VALSARTAN) VALSARTAN 320 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 4000 TITANIUM DIOXIDE TALC ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CROSPOVIDONE FERROSOFERRIC OXIDE

Product Characteristics Color BROWN (BROWN) Score no score Shape OVAL (OVAL) Size 21mm Flavor Imprint Code 283 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1489-9 90 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:70771-1489-0 1000 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:70771-1489-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1489-4)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203000 02/12/2020

Labeler — Cadila Healthcare Limited (918596198)

Registrant — Cadila Healthcare Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Cadila Healthcare Limited		918596198	ANALYSIS (70771-1485), ANALYSIS (70771-1486), ANALYSIS (70771-1487), ANALYSIS (70771-1488), ANALYSIS (70771-1489), MANUFACTURE (70771-1485), MANUFACTURE (70771-1486), MANUFACTURE (70771-1487), MANUFACTURE (70771-1488), MANUFACTURE (70771-1489)

Revised: 09/2020 Cadila Healthcare Limited