Label: LEVOFLOXACIN tablet, film coated

  • NDC Code(s): 65841-691-01, 65841-691-05, 65841-691-18, 65841-692-01, view more
    65841-692-05, 65841-692-10, 65841-692-18, 65841-693-01, 65841-693-05, 65841-693-06, 65841-693-18, 65841-693-92
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 16, 2024

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  • MEDICATION GUIDE

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-691-18 in bottle of 50 tablets

    Levofloxacin Tablets USP, 250 mg

    Rx only

    50 tablets

    Levofloxacin Tablets, 250 mg

    NDC 65841-692-18 in bottle of 50 tablets

    Levofloxacin Tablets USP, 500 mg

    Rx only

    50 tablets

    Levofloxacin Tablets, 500 mg

    NDC 65841-693-06 in bottle of 30 tablets

    Levofloxacin Tablets USP, 750 mg

    Rx only

    30 tablets

    Levofloxacin Tablets, 750 mg
  • INGREDIENTS AND APPEARANCE
    LEVOFLOXACIN 
    levofloxacin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-691
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS250 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (MODIFIED CAPSULE) Size15mm
    FlavorImprint Code ZC55
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-691-1850 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    2NDC:65841-691-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    3NDC:65841-691-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07765211/10/2012
    LEVOFLOXACIN 
    levofloxacin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-692
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (MODIFIED CAPSULE) Size19mm
    FlavorImprint Code ZC56
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-692-1850 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    2NDC:65841-692-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    3NDC:65841-692-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    4NDC:65841-692-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07765211/10/2010
    LEVOFLOXACIN 
    levofloxacin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-693
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS750 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (MODIFIED CAPSULE) Size22mm
    FlavorImprint Code ZC57
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-693-1850 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    2NDC:65841-693-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    3NDC:65841-693-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/10/2012
    4NDC:65841-693-9220 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2022
    5NDC:65841-693-0630 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07765211/10/2012
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-691, 65841-692, 65841-693) , MANUFACTURE(65841-691, 65841-692, 65841-693)
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