Label: LEVOFLOXACIN injection, solution

  • NDC Code(s): 70771-1079-2, 70771-1079-3
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 12, 2020

If you are a consumer or patient please visit this version.

  • MEDICATION GUIDE

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 MG/20 ML CONTAINER LABEL

    NDC 70771-1079-2

    Levofloxacin

    Injection

    500 mg/20 mL

    (25 mg/mL)

    For Intravenous Infusion

    Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.

    20 mL Single-Dose Vial

    Rx only

    zydus pharmaceuticals

    20 mL container label

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 MG/20 ML CARTON LABEL

    NDC 70771-1079-2

    Levofloxacin

    Injection

    500 mg/20 mL

    (25 mg/mL)

    For Intravenous Infusion

    Further Dilution Required

    Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.

    20 mL Single-Dose Vial

    Rx only

    zydus pharmaceuticals

    20 mL carton label

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 750 MG/30 ML CONTAINER LABEL

    NDC 70771-1079-3

    Levofloxacin

    Injection

    750 mg/30 mL

    (25 mg/mL)

    For Intravenous Infusion

    Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.

    30 mL Single-Dose Vial

    Rx only

    zydus pharmaceuticals

    30 mL container label

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 750 MG/30 ML CARTON LABEL

    NDC 70771-1079-3

    Levofloxacin

    Injection

    750 mg/30 mL

    (25 mg/mL)

    For Intravenous Infusion

    Further Dilution Required

    Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.

    30 mL Single-Dose Vial

    Rx only

    zydus pharmaceuticals

    30 mL carton label
  • INGREDIENTS AND APPEARANCE
    LEVOFLOXACIN 
    levofloxacin injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1079
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1079-220 mL in 1 VIAL; Type 0: Not a Combination Product08/01/2017
    2NDC:70771-1079-330 mL in 1 VIAL; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20596808/01/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1079) , MANUFACTURE(70771-1079)