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

Drug Label Information

Updated October 4, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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 65841-693-18 in bottle of 50 tablets

    Levofloxacin Tablets USP, 750 mg

    Rx only

    50 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!