Label: LONHALA- glycopyrrolate solution

  • NDC Code(s): 60940-024-01
  • Packager: Holopack Verpackungstechnik GmbH
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 12, 2019

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  • Lonhala

    (glycopyrrolate) inhalation solution, for oral inhalation use

  • PRINCIPAL DISPLAY PANEL - SHIPPER LABEL

    1 carton = 432 pouches

    Glycopyrrolate Inhalation Solution (25 µg/mL)

    Item No. 401732-001

    Lot: UE076

    Exp: 03-2019

    Caution: For manufacturing, processing, or repacking.

    Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]

    432 pouches with two 1.0 ml ampoules each

    Carton # 0034

    Made in Germany

    Sunovion Pharmaceuticals Inc.

    Marlborough, MA 01752 USA

    glycopyrrolate inhalation 25

  • INGREDIENTS AND APPEARANCE
    LONHALA 
    glycopyrrolate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60940-024
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE25 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60940-024-01432 in 1 CARTON12/05/2017
    12 in 1 POUCH
    11 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20843712/05/2017
    Labeler - Holopack Verpackungstechnik GmbH (313222457)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holopack Verpackungstechnik GmbH343390324manufacture(60940-024)