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

80 mg/ 12.5 mg
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)

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
(click image for full-size original)
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

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