Levofloxacin

• Indications and Usage – Oral solution and Injection Dosage Forms Removed ( 1 ) 7/2018 • Dosage and Administration – Oral Solution and Injection Dosage Forms Removed ( 2 ) 7/2018 • Warnings and Precautions,-Central Nervous System Effects ( 5.4 ) 10/2018 • Warnings and Precautions,- Risk of Aortic Aneurysm and Dissection ( 5.9 ) 05/2019 • Warnings and Precautions,- Blood Glucose Disturbances ( 5.13 ) 10/2018

1 INDICATIONS AND USAGE Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ). Pneumonia: Nosocomial ( 1.1 ) and Community Acquired ( 1.2, 1.3 ) Skin and Skin Structure Infections (SSSI): Complicated ( 1.4 ) and Uncomplicated ( 1.5 ) Chronic bacterial prostatitis ( 1.6 ) Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1.7 ) Plague in adult and pediatric patients ( 1.8 ) Urinary Tract Infections (UTI): Complicated ( 1.9 , 1.10 ) and Uncomplicated ( 1.12 ) Acute Pyelonephritis ( 1.11 ) Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13 ) Acute Bacterial Sinusitis ( 1.14 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.15 ). 1.1 Nosocomial Pneumonia Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae . Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1) ] . 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2 )]. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2 nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3) ]. 1.4 Complicated Skin and Skin Structure Infections Levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5) ]. 1.5 Uncomplicated Skin and Skin Structure Infections Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes . 1.6 Chronic Bacterial Prostatitis Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6) ]. 1.7 Inhalational Anthrax (Post-Exposure) Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in adults and pediatric patients, 6 mon …

2 DOSAGE AND ADMINISTRATION Administer levofloxacin tablets to pediatric patients weighing 30 kg and greater only ( 2.1 , 2.2 ). Levofloxacin tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg ( 2.2 ). Dosage in Adult and Pediatric Patients with Creatinine Clearance greater than or equal to 50 mL/minute ( 2.1 . 2.2 ) Type of Infection Dose Every 24 hours Duration (days) Nosocomial Pneumonia ( 1.1 ) 750 mg 7 to 14 Community Acquired Pneumonia ( 1.2 ) 500 mg 7 to 14 Community Acquired Pneumonia ( 1.3 ) 750 mg 5 Complicated SSSI ( 1.4 ) 750 mg 7 to 14 Uncomplicated SSSI ( 1.5 ) 500 mg 7 to 10 Chronic Bacterial Prostatitis ( 1.6 ) 500 mg 28 Inhalational Anthrax (Post-Exposure) ( 1.7 ) Adults and Pediatric Patients 50 kg or greater Pediatric Patients 30 kg to less than 50 kg ( 2.2 ) 500 mg 250 mg every 12 hours 60 60 Plague ( 1.8 ) Adults and Pediatric Patients 50 kg or greater Pediatric Patients 30 kg to less than 50 kg ( 2.2 ) 500 mg 250 mg every 12 hours 10 to 14 10 to 14 Complicated UTI ( 1.9 ) or Acute Pyelonephritis ( 1.11 ) 750 mg 5 Complicated UTI ( 1.10 ) or Acute Pyelonephritis ( 1.11 ) 250 mg 10 Uncomplicated UTI ( 1.12 ) 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13 ) 500 mg 7 Acute Bacterial Sinusitis ( 1.14 ) 750 mg 5 500 mg 10 to 14 Adjust dose for creatinine clearance less than 50 mL/minute ( 2.3 , 8.6 , 12.3 ) 2.1 Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance ≥ 50 mL/minute The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1. These recommendations apply to patients with creatinine clearance ≥ 50 mL/minute. For patients with creatinine clearance less than 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration ( 2.3 )] . Table 1: Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance greater than or equal to 50 mL/minute * Due to the designated pathogens [see Indications and Usage ( 1 )] . † Sequential therapy (intravenous levofloxacin to oral levofloxacin tablets) may be instituted at the discretion of the healthcare provider. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage ( 1.2 )] . § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage ( 1.3 )] . ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli , including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa ; and for AP due to E. coli . Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies ( 14.9 )] . ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions ( 5.12 ), Use in Specific Populations ( 8.4 ), and Clinical Studies ( 14.9 …

3 DOSAGE FORMS & STRENGTHS • Levofloxacin tablets, USP 250 mg are pink colored, capsule shaped, biconvex, film coated tablets debossed with '25on' one side and 'I' on the other side. • Levofloxacin tablets, USP 500 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with '26' on one side and 'I' on the other side. • Levofloxacin tablets, USP 750 mg are white colored, capsule shaped, biconvex, film coated tablets debossed with '18'on one side and 'I' on the other side. Formulation ( 3 ) Strength Tablets 250 mg, 500 mg, and 750 mg

4 CONTRAINDICATIONS Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )]. Known hypersensitivity to levofloxacin tablets or other quinolones ( 4 , 5.7 )

6 ADVERSE REACTIONS The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: • Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions (5.1) ] • Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2 )] • Peripheral Neuropathy [see Warnings and Precautions ( 5.3 )] • Central Nervous System Effects [see Warnings and Precautions ( 5.4 )] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5) ] • Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions ( 5.6) ] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] • Hepatotoxicity [see Warnings and Precautions ( 5.8) ] • Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9 )] • Clostridium difficile- Associated Diarrhea [see Warnings and Precautions ( 5.10) ] • Prolongation of the QT Interval [see Warnings and Precautions ( 5.11 )] • Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.12 )] • Blood Glucose Disturbances [see Warnings and Precautions ( 5.13 )] • Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.14) ] • Development of Drug Resistant Bacteria [see Warnings and Precautions ( 5.15) ] Crystalluria and cylindruria have been reported with quinolones, including levofloxacin. Therefore, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of a highly concentrated urine [see Dosage and Administration ( 2.5 )]. The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness ( Error! Hyperlink reference not valid.) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to levofloxacin in 7537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with levofloxacin for a wide variety of infectious diseases [see ]. Patients received levofloxacin doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3 to 14 days, and the mean number of days on therapy was 10 days. The overall incidence, type and distribution of adverse reactions was similar in patients receiving levofloxacin doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of levofloxacin due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%). Adverse reactions occurring in ≥1% of levofloxacin-treated patients and less common adverse reactions, occurring in 0.1 to <1% of levofloxacin-treated patients, are shown in Table 4 and Table 5, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness. Table 4: Common (≥1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin System/Organ Class Adverse Reaction % (N=7,537) Infections and Infest …

7 DRUG INTERACTIONS Interacting Drug Interaction Multivalent cation-containing products including antacids, metal cations or didanosine Absorption of levofloxacin is decreased when the tablet formulation is taken within 2 hours of these products. ( 2.4 , 7.1 ) Warfarin Effect may be enhanced. Monitor prothrombin time, INR, watch for bleeding ( 7.2 ) Antidiabetic agents Carefully monitor blood glucose ( 5.12 , 7.3 ) 7.1 Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins Levofloxacin Tablets While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of levofloxacin tablets with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. Tablets with antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine may substantially interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after oral levofloxacin administration. 7.2 Warfarin No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for R- and S- warfarin was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of warfarin on levofloxacin absorption and disposition was observed. However, there have been reports during the postmarketing experience in patients that levofloxacin enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and levofloxacin use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if levofloxacin is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding [see Adverse Reactions ( 6.3 ); Patient Counseling Information ( Error! Hyperlink reference not valid. )] . 7.3 Antidiabetic Agents Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered [see Warnings and Precautions ( 5.12 ); Adverse Reactions ( 6.2 ), Patient Counseling Information ( Error! Hyperlink reference not valid. )] . 7.4 Non-Steroidal Anti-Inflammatory Drugs The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including levofloxacin, may increase the risk of CNS stimulation and convulsive seizures [see Warnings and Precautions ( 5.4 )] . 7.5 Theophylline No significant effect of levofloxacin on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of theophylline on levofloxacin absorption and disposition was observed. However, concomitant administration of other fluoroquinolones with theophylline has resulted in prolonged elimination half-life, elevated serum theophylline levels, and a subsequent increase in the risk of theophylline-related adverse reactions in the patient population. Therefore, theophylline levels should be closely monitored and appropriate dosage adjustments made when levofloxacin is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels [see Warnings and Precautions ( 5.4 )] . 7.6 Cyclosporine No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected …

8 USE IN SPECIFIC POPULATIONS • Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older ( 5.8 , 8.5 , 17 ). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use ( 5.2 , 8.5 , 17 ). May be more susceptible to prolongation of the QT interval. ( 5.11 , 8.5 , 17 ). • Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) seen in more levofloxacin-treated patients than in comparator. Shown to cause arthropathy and osteochondrosis in juvenile animals ( 5.12 , 8.4 , 13.2 ). Safety in pediatric patients treated for more than 14 days has not been studied. Risk-benefit appropriate only for the treatment of inhalational anthrax (post-exposure) ( 1.7 , 2.2 , 8.4 , 14.9 ) and plague ( 1.8 , 2.2 , 8.4 , 14.10 ) • Lactation: Breastfeeding is not recommended during treatment, but a lactating woman may pump and discard breastmilk during treatment and an additional 2 days after the last dose. In patients treated for inhalational anthrax (post exposure), consider the risks and benefits of continuing breastfeeding. 8.1 Pregnancy Risk Summary Published information from case reports, case control studies and observational studies on levofloxacin administered during pregnancy have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of levofloxacin to pregnant rats and rabbits during organogenesis at doses up to 9.4 times and 1.1 times the maximum recommended human dose (MRHD), respectively, did not result in teratogenicity. Fetal toxicity was seen in the rat study, but was absent at doses up to 1.2 times the maximum recommended human dose (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Levofloxacin was not teratogenic in an embryofetal development study in rats treated during organogenesis with oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the MRHD (based upon doses normalized for total body surface area). The oral dose of 810 mg/kg/day (high dose) to rats caused decreased fetal body weight and increased fetal mortality that was not seen at the next lower dose (mid-dose, 90 mg/kg/day, equivalent to 1.2 times the MRHD (based upon doses normalized for total body surface area). Maternal toxicity was limited to lower weight gain in the mid and high dose groups. No teratogenicity was observed in an embryofetal development study in rabbits dosed orally during organogenesis with doses as high as 50 mg/kg/day, which corresponds to 1.1 times the MRHD (based upon doses normalized for total body surface area). Maternal toxicity at that dose consisted of lower weight gain and decreased food consumption relative to controls and abortion in four of sixteen dams. 8.2 Lactation Risk Summary Published literature reports that levofloxacin is present in human milk following intravenous and oral administration ( see Data ). There is no information regarding effects of levofloxacin on milk production or the breastfed infant. Because of the potential risks of serious adverse reactions, in breastfed infants, for most indications, a lactating woman may consider pumping and discarding breast milk during treatment with levofloxacin and an additional two days (five half-lives) after the last dose. Alternatively, advise a lactating woman that breastfeeding is not recommended during treatment with levofloxacin and for an additional two days (five half-lives) after the last dose [see Use in Specific Populations (8.4) and Clinical Phar …

12.1 Mechanism of Action Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology ( 12.4 )] .

11 DESCRIPTION Levofloxacin tablets are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin The empirical formula is C 18 H 20 FN 3 O 4 • 1⁄2 H 2 O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3 >Cu +2 >Zn +2 >Mg +2 >Ca +2 . Levofloxacin tablets USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg (as expressed in the anhydrous form): crospovidone, hypromellose, iron oxide black, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, shellac and titanium dioxide. 500 mg (as expressed in the anhydrous form): crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, shellac and titanium dioxide. 750 mg (as expressed in the anhydrous form): crospovidone, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, shellac and titanium dioxide. Levofloxacin tablets USP meets USP Dissolution Test 2. Image

10. Overdosage In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis. Levofloxacin exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of levofloxacin: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 mg/kg orally (approximately 10 or 19 times MRHD in mice and rats, respectively) and 250 mg/kg IV produced significant mortality (estimated to be greater than or equal to 50%) in rodents.

16 HOW SUPPLIED/STORAGE AND HANDLING Levofloxacin Tablets USP, 250 mg are terra pink colored capsule shaped, biconvex film-coated tablets, debossed with ‘13’ on one side and ‘T’ on the other side. Bottles of 5 NDC 76420-815-05 (repackaged from NDC 65862-536-XX) Bottles of 7 NDC 76420-815-07 (repackaged from NDC 65862-536-XX) Bottles of 10 NDC 76420-815-10 (repackaged from NDC 65862-536-XX) Bottles of 14 NDC 76420-815-14 (repackaged from NDC 65862-536-XX) Bottles of 20 NDC 76420-815-20 (repackaged from NDC 65862-536-XX) Bottles of 30 NDC 76420-815-30 (repackaged from NDC 65862-536-XX) Bottles of 50 NDC 76420-815-50 (relabeled from NDC 65862-536-50) Bottles of 60 NDC 76420-815-60 (repackaged from NDC 65862-536-XX) Bottles of 90 NDC 76420-815-90 (repackaged from NDC 65862-536-XX) Bottles of 1000 NDC 76420-815-00 (relabeled from NDC 65862-536-99) Levofloxacin Tablets USP, 500 mg are peach colored capsule shaped, biconvex film-coated tablets, debossed with ‘12’ on one side and ‘T’ on the other side. Bottles of 5 NDC 76420-816-05 (repackaged from NDC 65862-537-XX) Bottles of 7 NDC 76420-816-07 (repackaged from NDC 65862-537-XX) Bottles of 10 NDC 76420-816-10 (repackaged from NDC 65862-537-XX) Bottles of 14 NDC 76420-816-14 (repackaged from NDC 65862-537-XX) Bottles of 20 NDC 76420-816-20 (repackaged from NDC 65862-537-XX) Bottles of 30 NDC 76420-816-30 (repackaged from NDC 65862-537-XX) Bottles of 50 NDC 76420-816-50 (relabeled from NDC 65862-537-50) Bottles of 60 NDC 76420-816-60 (repackaged from NDC 65862-537-XX) Bottles of 90 NDC 76420-816-90 (repackaged from NDC 65862-537-XX) Bottles of 1000 NDC 76420-816-00 (relabeled from NDC 65862-537-99) Levofloxacin Tablets USP, 750 mg are white capsule shaped, biconvex film-coated tablets, debossed with ‘11’ on one side and ‘T’ on the other side. Bottles of 5 NDC 76420-817-05 (repackaged from NDC 65862-538-XX) Bottles of 7 NDC 76420-817-07 (repackaged from NDC 65862-538-XX) Bottles of 10 NDC 76420-817-10 (repackaged from NDC 65862-538-XX) Bottles of 14 NDC 76420-817-14 (repackaged from NDC 65862-538-XX) Bottles of 20 NDC 76420-817-20 (relabeled from NDC 65862-538-20) Bottles of 30 NDC 76420-817-30 (repackaged from NDC 65862-538-XX) Bottles of 50 NDC 76420-817-50 (repackaged from NDC 65862-538-XX) Bottles of 60 NDC 76420-817-60 (repackaged from NDC 65862-538-XX) Bottles of 90 NDC 76420-817-90 (repackaged from NDC 65862-538-XX) Bottles of 500 NDC 76420-817-55 (relabeled from NDC 65862-538-05) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in well-closed containers.