Label: STRENZA- moxifloxacin 0.5%, ketorolac tromethamine 0.5%, prednisolone acetate 1% kit

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 16, 2024

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  • DESCRIPTION

    Rx Only

    NDC 73614-731-03

    For Use in Eyes Only

    STRENZA tm

    Each Pack Contains:

    Moxifloxacin Ophthalmic Solution, USP 0.5% - 3ml Bottle

    Ketorolac Tromethamine Ophthalmic Solution, 0.5% - 5ml Bottle
    Prednisolone Acetate Ophthalmic Suspension, USP 1% - 5ml Bottle

    Brisk Pharmaceuticals

  • DESCRIPTION

    Keep out of the reach of children.

    TAMPER EVIDENT: Do not use the individual
    eye drops inside the pack if the seal on its
    bottle is broken or missing.

    Lot: See the lot number on each individual
    bottle inside the pack.
    Exp: See the expiration date on each
    individual bottle inside the pack.

    Packaged by:
    Unit Dose Solutions Inc.,
    Morrisville, NC 27560
    Distributed by:
    Brisk pharmaceuticals,
    Richardson, TX 75081

  • PATIENT MEDICATION INFORMATION

    leaflet

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    STRENZA 
    moxifloxacin 0.5%, ketorolac tromethamine 0.5%, prednisolone acetate 1% kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73614-731
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73614-731-031 in 1 CARTON; Type 1: Convenience Kit of Co-Package10/16/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, DROPPER 5 mL
    Part 21 BOTTLE, PLASTIC 5 mL
    Part 31 BOTTLE 3 mL
    Part 1 of 3
    KETOROLAC TROMETHAMINE 
    ketorolac tromethamine solution/ drops
    Product Information
    Item Code (Source)NDC:69315-322
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L) KETOROLAC TROMETHAMINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OCTOXYNOL-40 (UNII: 9T1C662FKS)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21820406/01/2024
    Part 2 of 3
    PREDNISOLONE ACETATE 
    prednisolone acetate suspension/ drops
    Product Information
    Item Code (Source)NDC:61314-637
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PREDNISOLONE ACETATE (UNII: 8B2807733D) (PREDNISOLONE - UNII:9PHQ9Y1OLM) PREDNISOLONE ACETATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA01746912/15/1994
    Part 3 of 3
    MOXIFLOXACIN 
    moxifloxacin solution/ drops
    Product Information
    Item Code (Source)NDC:68180-422
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE (UNII: B8956S8609) (MOXIFLOXACIN - UNII:U188XYD42P) MOXIFLOXACIN5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Coloryellow (Yellow Colored Transparent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20286707/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/16/2024
    Labeler - Brisk Pharmaceuticals (117250794)
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