Home SPL Set DailyMed Tadalafil Tablets Tadalafil Tablets SPL v4 SPL SPL Set ID 6c1c3a1f-80a4-417c-8830-5edbb9a0710f Route ORAL Published Effective Date 2024-08-12 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Tadalafil (2.5 mg) Inactive Ingredients Cellulose, Microcrystalline Croscarmellose Sodium Hydroxypropyl Cellulose, Unspecified Hypromelloses Lactose Monohydrate Magnesium Stearate Talc Titanium Dioxide Triacetin Ferric Oxide Yellow Identifiers & Packaging Pill Appearance Imprint: 897 Shape: capsule Shape: oval Color: white Color: yellow Size: 6 mm Size: 10 mm Size: 13 mm Size: 8 mm Score: 1 Marketing Status ANDA Active Since 2019-03-27 Description NDC 70771-1475-3 in bottle of 30 tablets Tadalafil Tablets USP, 2.5 mg Rx Only 30 tablets NDC 70771-1476-3 in bottle of 30 tablets Tadalafil Tablets USP, 5 mg Rx Only 30 tablets NDC 70771-1477-3 in bottle of 30 tablets Tadalafil Tablets USP, 10 mg Rx Only 30 tablets NDC 70771-1478-3 in bottle of 30 tablets Tadalafil Tablets USP, 20 mg Rx Only 30 tablets Medication Information Description NDC 70771-1475-3 in bottle of 30 tablets Tadalafil Tablets USP, 2.5 mg Rx Only 30 tablets NDC 70771-1476-3 in bottle of 30 tablets Tadalafil Tablets USP, 5 mg Rx Only 30 tablets NDC 70771-1477-3 in bottle of 30 tablets Tadalafil Tablets USP, 10 mg Rx Only 30 tablets NDC 70771-1478-3 in bottle of 30 tablets Tadalafil Tablets USP, 20 mg Rx Only 30 tablets Package Label.principal Display Panel NDC 70771-1475-3 in bottle of 30 tablets Tadalafil Tablets USP, 2.5 mg Rx Only 30 tablets NDC 70771-1476-3 in bottle of 30 tablets Tadalafil Tablets USP, 5 mg Rx Only 30 tablets NDC 70771-1477-3 in bottle of 30 tablets Tadalafil Tablets USP, 10 mg Rx Only 30 tablets NDC 70771-1478-3 in bottle of 30 tablets Tadalafil Tablets USP, 20 mg Rx Only 30 tablets Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) NDC 70771-1475-3 in bottle of 30 tablets Tadalafil Tablets USP, 2.5 mg Rx Only 30 tablets NDC 70771-1476-3 in bottle of 30 tablets Tadalafil Tablets USP, 5 mg Rx Only 30 tablets NDC 70771-1477-3 in bottle of 30 tablets Tadalafil Tablets USP, 10 mg Rx Only 30 tablets NDC 70771-1478-3 in bottle of 30 tablets Tadalafil Tablets USP, 20 mg Rx Only 30 tablets Advanced Ingredient Data [{"name": "TADALAFIL", "unii": "742SXX0ICT", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", 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{"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "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": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": 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{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TADALAFIL", "unii": "742SXX0ICT", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE, UNSPECIFIED", "unii": "9XZ8H6N6OH", "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": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1475-3 in bottle of 30 tablets Tadalafil Tablets USP, 2.5 mg Rx Only 30 tablets NDC 70771-1476-3 in bottle of 30 tablets Tadalafil Tablets USP, 5 mg Rx Only 30 tablets NDC 70771-1477-3 in bottle of 30 tablets Tadalafil Tablets USP, 10 mg Rx Only 30 tablets NDC 70771-1478-3 in bottle of 30 tablets Tadalafil Tablets USP, 20 mg Rx Only 30 tablets"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:42:26.135032 · Updated: 2026-03-14T22:09:11.898870
