Label: ENTECAVIR tablet, film coated
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NDC Code(s):
70771-1019-1,
70771-1019-2,
70771-1019-3,
70771-1019-4, view more70771-1019-9, 70771-1020-1, 70771-1020-2, 70771-1020-3, 70771-1020-4, 70771-1020-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 26, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ENTECAVIR
entecavir tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1019 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENTECAVIR (UNII: 5968Y6H45M) (ENTECAVIR ANHYDROUS - UNII:NNU2O4609D) ENTECAVIR 0.5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code 920 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1019-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 2 NDC:70771-1019-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 3 NDC:70771-1019-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 4 NDC:70771-1019-4 10 in 1 CARTON 08/10/2017 4 NDC:70771-1019-2 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 ANDA206745 08/10/2017 ENTECAVIR
entecavir tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENTECAVIR (UNII: 5968Y6H45M) (ENTECAVIR ANHYDROUS - UNII:NNU2O4609D) ENTECAVIR 1 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (LIGHT-PINK TO PINK) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 921 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1020-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 2 NDC:70771-1020-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 3 NDC:70771-1020-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2017 4 NDC:70771-1020-4 10 in 1 CARTON 08/10/2017 4 NDC:70771-1020-2 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 ANDA206745 08/10/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1019, 70771-1020) , MANUFACTURE(70771-1019, 70771-1020)
