Label: VALSARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated
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NDC Code(s):
70771-1485-0,
70771-1485-4,
70771-1485-9,
70771-1486-0, view more70771-1486-4, 70771-1486-9, 70771-1487-0, 70771-1487-4, 70771-1487-9, 70771-1488-0, 70771-1488-4, 70771-1488-9, 70771-1489-0, 70771-1489-4, 70771-1489-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
VALSARTAN AND HYDROCHLOROTHIAZIDE
valsartan and hydrochlorothiazide tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1485 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 80 mg HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 12.5 mg Inactive Ingredients Ingredient Name Strength 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 Color PINK (PINK) Score no score Shape OVAL (OVAL) Size 12mm Flavor Imprint Code 279 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1485-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 2 NDC:70771-1485-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 3 NDC:70771-1485-4 10 in 1 CARTON 02/12/2020 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 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 coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1486 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 160 mg HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 12.5 mg Inactive Ingredients Ingredient Name Strength 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 Color BROWN (brownish red) Score no score Shape OVAL (OVAL) Size 17mm Flavor Imprint Code 280 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1486-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 2 NDC:70771-1486-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 3 NDC:70771-1486-4 10 in 1 CARTON 02/12/2020 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 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 coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1487 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 160 mg HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 25 mg Inactive Ingredients Ingredient Name Strength 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 Color BROWN (BROWN) Score no score Shape OVAL (oval) Size 17mm Flavor Imprint Code 282 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1487-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 2 NDC:70771-1487-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 3 NDC:70771-1487-4 10 in 1 CARTON 02/12/2020 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 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 coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1488 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 320 mg HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 12.5 mg Inactive Ingredients Ingredient Name Strength 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 Color PINK (pink) Score no score Shape OVAL (oval) Size 21mm Flavor Imprint Code 281 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1488-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 2 NDC:70771-1488-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 3 NDC:70771-1488-4 10 in 1 CARTON 02/12/2020 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 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 coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1489 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 320 mg HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE 25 mg Inactive Ingredients Ingredient Name Strength 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 Color BROWN (BROWN) Score no score Shape OVAL (OVAL) Size 21mm Flavor Imprint Code 283 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1489-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 2 NDC:70771-1489-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2020 3 NDC:70771-1489-4 10 in 1 CARTON 02/12/2020 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203000 02/12/2020 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1485, 70771-1486, 70771-1487, 70771-1488, 70771-1489) , MANUFACTURE(70771-1485, 70771-1486, 70771-1487, 70771-1488, 70771-1489)