Label: VARDENAFIL tablet, film coated
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NDC Code(s):
70771-1047-1,
70771-1047-3,
70771-1047-9,
70771-1048-1, view more70771-1048-3, 70771-1048-9, 70771-1049-1, 70771-1049-3, 70771-1049-9, 70771-1050-1, 70771-1050-3, 70771-1050-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 14, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VARDENAFIL
vardenafil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1047 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL 2.5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 5mm Flavor Imprint Code 10;68 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1047-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 2 NDC:70771-1047-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 3 NDC:70771-1047-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208960 11/01/2018 VARDENAFIL
vardenafil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1048 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 5mm Flavor Imprint Code 10;69 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1048-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 2 NDC:70771-1048-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 3 NDC:70771-1048-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208960 11/01/2018 VARDENAFIL
vardenafil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1049 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL 10 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (LIGHT YELLOW TO ORANGE) Score no score Shape ROUND (ROUND) Size 7mm Flavor Imprint Code 10;70 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1049-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 2 NDC:70771-1049-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 3 NDC:70771-1049-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208960 11/01/2018 VARDENAFIL
vardenafil tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1050 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VARDENAFIL HYDROCHLORIDE TRIHYDRATE (UNII: 5M8S2CU0TS) (VARDENAFIL - UNII:UCE6F4125H) VARDENAFIL 20 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (LIGHT YELLOW TO ORANGE) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code 10;71 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1050-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 2 NDC:70771-1050-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 3 NDC:70771-1050-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208960 11/01/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (863362789) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1047, 70771-1048, 70771-1049, 70771-1050) , MANUFACTURE(70771-1047, 70771-1048, 70771-1049, 70771-1050)
