Label: VALSARTAN tablet, film coated
- NDC Code(s): 70771-1882-3, 70771-1883-9, 70771-1884-9, 70771-1885-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 23, 2024
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INGREDIENTS AND APPEARANCE
VALSARTAN
valsartan tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1882 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 40 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (light yellow to yellow) Score 2 pieces Shape OVAL Size 8mm Flavor Imprint Code T;4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1882-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218991 08/30/2024 VALSARTAN
valsartan tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1883 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 80 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (light pink to pink) Score no score Shape OVAL Size 10mm Flavor Imprint Code T7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1883-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218991 08/30/2024 VALSARTAN
valsartan tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1884 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 160 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (light yellow to yellow) Score no score Shape OVAL Size 12mm Flavor Imprint Code 277 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1884-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218991 08/30/2024 VALSARTAN
valsartan tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1885 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN 320 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BROWN (light brown to brown) Score no score Shape OVAL Size 16mm Flavor Imprint Code 278 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1885-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218991 08/30/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Pharmaceuticals Limited 650173735 MANUFACTURE(70771-1882, 70771-1883, 70771-1884, 70771-1885) , ANALYSIS(70771-1882, 70771-1883, 70771-1884, 70771-1885)
