Label: STRENZA PLUS- moxifloxacin 0.5%, bromfenac 0.09%, prednisolone acetate 1% kit

  • NDC Code(s): 72266-142-01, 73614-732-03
  • Packager: Brisk Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 12, 2025

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  • DESCRIPTION

    Rx Only

    NDC 73614-732-03

    For Use in Eyes Only

    STRENZA Plus ™

    Each Pack Contains:

    Moxifloxacin Ophthalmic Solution, USP 0.5% - One 3 ml Bottle

    Bromfenac Ophthalmic Solution 0.09% - One 1.7 ml Bottle

    Prednisolone Acetate Ophthalmic Suspension, USP 1% - One 5 ml Bottle

    Brisk Pharmaceuticals

  • DESCRIPTION

    Packaged by:

    Unit Dose Solutions Inc.,

    Morrisville, NC 27560

    Distributed by:

    Brisk pharmaceuticals,

    Richardson, TX 75081

    Keep out of 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.

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    STRENZA PLUS 
    moxifloxacin 0.5%, bromfenac 0.09%, prednisolone acetate 1% kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73614-732
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73614-732-031 in 1 CARTON; Type 1: Convenience Kit of Co-Package02/10/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 3 mL
    Part 21 BOTTLE, PLASTIC 5 mL
    Part 31 BOTTLE, DROPPER 1.7 mL
    Part 1 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)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    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
    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
    BROMFENAC 
    bromfenac solution/ drops
    Product Information
    Item Code (Source)NDC:72266-142
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMFENAC SODIUM (UNII: 8ECV571Y37) (BROMFENAC - UNII:864P0921DW) BROMFENAC0.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 0.05 mg  in 1 mL
    BORIC ACID (UNII: R57ZHV85D4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72266-142-011 in 1 CARTON
    11.7 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21102907/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/10/2025
    Labeler - Brisk Pharmaceuticals (117250794)
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