Label: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution

  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated November 10, 2022

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    BULK LABEL

    NDC 68083-231-85

    Olopatadine Hydrochloride Ophthalmic Solution, USP, 0.2%

    Quantity- 1000 - 2.5 mL Bottles

    Batch No. :

    Mfg. Date :

    Repack

    Before :

    Expiration Date : MM/YYYY

    Store at 2°-25°C (36°-77°F)

    CAUTION: For Manufacturing, processing or repackaging only.

    Manufactured by :

    Gland Pharma Limited 

    D.P. Pally, Hyderabad - 500043, INDIA

    Code: AP/DRUGS/103/97
    olopatadine-spl-shipper

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
    olopatadine hydrochloride ophthalmic solution
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:68083-231
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68083-231-851000 in 1 CASE08/20/2020
    12.5 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EXPORT ONLY08/20/2020
    Labeler - Gland Pharma Limited (918601238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gland Pharma Limited918601238ANALYSIS(68083-231) , MANUFACTURE(68083-231) , PACK(68083-231)
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