Home SPL Set DailyMed Levofloxacin Tablets Levofloxacin Tablets SPL v11 SPL SPL Set ID ffa121b8-388f-4d7b-af48-d4aa8d9b5961 Route ORAL Published Effective Date 2024-08-16 Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL Drug Facts Composition & Product Active Ingredients Levofloxacin Anhydrous (250 mg) Inactive Ingredients Crospovidone (15 Mpa.s At 5%) Hypromelloses Magnesium Stearate Polyethylene Glycol 6000 Talc Titanium Dioxide Cellulose, Microcrystalline Identifiers & Packaging Pill Appearance Imprint: ZC57 Shape: capsule Color: white Size: 15 mm Size: 19 mm Size: 22 mm Score: 1 Marketing Status ANDA Active Since 2012-11-10 Description NDC 65841-691-18 in bottle of 50 tablets Levofloxacin Tablets USP, 250 mg Rx only 50 tablets NDC 65841-692-18 in bottle of 50 tablets Levofloxacin Tablets USP, 500 mg Rx only 50 tablets NDC 65841-693-06 in bottle of 30 tablets Levofloxacin Tablets USP, 750 mg Rx only 30 tablets Medication Information Description NDC 65841-691-18 in bottle of 50 tablets Levofloxacin Tablets USP, 250 mg Rx only 50 tablets NDC 65841-692-18 in bottle of 50 tablets Levofloxacin Tablets USP, 500 mg Rx only 50 tablets NDC 65841-693-06 in bottle of 30 tablets Levofloxacin Tablets USP, 750 mg Rx only 30 tablets Package Label.principal Display Panel NDC 65841-691-18 in bottle of 50 tablets Levofloxacin Tablets USP, 250 mg Rx only 50 tablets NDC 65841-692-18 in bottle of 50 tablets Levofloxacin Tablets USP, 500 mg Rx only 50 tablets NDC 65841-693-06 in bottle of 30 tablets Levofloxacin Tablets USP, 750 mg Rx only 30 tablets Structured Label Content Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL) NDC 65841-691-18 in bottle of 50 tablets Levofloxacin Tablets USP, 250 mg Rx only 50 tablets NDC 65841-692-18 in bottle of 50 tablets Levofloxacin Tablets USP, 500 mg Rx only 50 tablets NDC 65841-693-06 in bottle of 30 tablets Levofloxacin Tablets USP, 750 mg Rx only 30 tablets Advanced Ingredient Data [{"name": "LEVOFLOXACIN 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"strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEVOFLOXACIN ANHYDROUS", "unii": "RIX4E89Y14", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSPOVIDONE (15 MPA.S AT 5%)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 6000", "unii": "30IQX730WE", "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": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEVOFLOXACIN ANHYDROUS", "unii": "RIX4E89Y14", "classCode": "ACTIM", "strengthNumerator": "750", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSPOVIDONE (15 MPA.S AT 5%)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 6000", "unii": "30IQX730WE", "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": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}] Raw Label Data All Sections (JSON) {"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 65841-691-18 in bottle of 50 tablets Levofloxacin Tablets USP, 250 mg Rx only 50 tablets NDC 65841-692-18 in bottle of 50 tablets Levofloxacin Tablets USP, 500 mg Rx only 50 tablets NDC 65841-693-06 in bottle of 30 tablets Levofloxacin Tablets USP, 750 mg Rx only 30 tablets"} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T11:42:33.129344 · Updated: 2026-03-14T22:09:49.950257