Home SPL Set DailyMed Entecavir Tablets Entecavir Tablets SPL v6 SPL SPL Set ID 0e3b2a0a-9076-4907-bbaf-eb6a65bb9481 Route ORAL Published Effective Date 2022-08-26 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Entecavir Anhydrous (0.5 mg) Inactive Ingredients Cellulose, Microcrystalline Crospovidone Hypromelloses Lactose Monohydrate Magnesium Stearate Polyethylene Glycol, Unspecified Talc Titanium Dioxide Ferric Oxide Red Ferric Oxide Yellow Identifiers & Packaging Pill Appearance Imprint: 921 Shape: round Color: white Color: pink Size: 8 mm Size: 10 mm Score: 1 Marketing Status ANDA Active Since 2017-08-10 Description NDC 70771-1019-3 Entecavir Tablets USP, 0.5 mg Rx Only 30 tablets NDC 70771-1020-3 Entecavir Tablets USP, 1 mg Rx Only 30 tablets Medication Information Description NDC 70771-1019-3 Entecavir Tablets USP, 0.5 mg Rx Only 30 tablets NDC 70771-1020-3 Entecavir Tablets USP, 1 mg Rx Only 30 tablets Package Label.principal Display Panel NDC 70771-1019-3 Entecavir Tablets USP, 0.5 mg Rx Only 30 tablets NDC 70771-1020-3 Entecavir Tablets USP, 1 mg Rx Only 30 tablets Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) NDC 70771-1019-3 Entecavir Tablets USP, 0.5 mg Rx Only 30 tablets NDC 70771-1020-3 Entecavir Tablets USP, 1 mg Rx Only 30 tablets Advanced Ingredient Data [{"name": "ENTECAVIR ANHYDROUS", "unii": "NNU2O4609D", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ENTECAVIR ANHYDROUS", "unii": "NNU2O4609D", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1019-3 Entecavir Tablets USP, 0.5 mg Rx Only 30 tablets NDC 70771-1020-3 Entecavir Tablets USP, 1 mg Rx Only 30 tablets"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:43:58.920035 · Updated: 2026-03-14T22:18:18.443233