Label: ADVAIR DISKUS- fluticasone propionate and salmeterol powder

  • NDC Code(s): 63379-043-00, 63379-044-00, 63379-045-00
  • Packager: Glaxo Operations UK Ltd
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Drug Label Information

Updated November 21, 2017

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    NDC 0173-0695-00

    ADVAIR DISKUS® 100/50

    (fluticasone propionate 100 mcg and salmeterol* 50 mcg inhalation powder)

    FOR ORAL INHALATION ONLY

    * Each blister contains 100 mcg of fluticasone propionate and 72.5 mcg of salmeterol xinafoate, equivalent to 50 mcg of salmeterol base, with lactose.

    Federal Law requires the dispensing of ADVAIR DISKUS with the Medication Guide inside the carton.

    Rx only

    1 DISKUS® Inhalation Device Containing 1 Foil Strip of 60 Blisters

    ©2016 the GSK group of companies

     
    10000000142019 Rev. 7/16
    Advair Diskus 100mg-50mg carton
    Close
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    NDC 0173-0696-00

    ADVAIR DISKUS®250/50

    (fluticasone propionate 250 mcg and salmeterol* 50 mcg inhalation powder)

    FOR ORAL INHALATION ONLY

    * Each blister contains 250 mcg of fluticasone propionate and 72.5 mcg of salmeterol xinafoate, equivalent to 50 mcg of salmeterol base, with lactose.

    Federal Law requires the dispensing of ADVAIR DISKUS with the Medication Guide inside the carton.

    Rx only

    1 DISKUS® Inhalation Device Containing 1 Foil Strip of 60 Blisters

    ©2016 the GSK group of companies

     
    10000000142020 Rev. 7/16
    Advair Diskus 250mg-50mg carton
    Close
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    NDC 0173-0697-00

    ADVAIR DISKUS®500/50

    (fluticasone propionate 500 mcg and salmeterol* 50 mcg inhalation powder)

    FOR ORAL INHALATION ONLY

    * Each blister contains 500 mcg of fluticasone propionate and 72.5 mcg of salmeterol xinafoate, equivalent to 50 mcg of salmeterol base, with lactose.

    Federal Law requires the dispensing of ADVAIR DISKUS with the Medication Guide inside the carton.

    Rx only

    1 DISKUS® Inhalation Device Containing 1 Foil Strip of 60 Blisters

    ©2016 the GSK group of companies

     
    10000000142021 Rev. 7/16
    Advair Diskus 500mg-50mg carton
    Close
  • INGREDIENTS AND APPEARANCE
    ADVAIR  DISKUS
    fluticasone propionate and salmeterol powder
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63379-043
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT) SALMETEROL 50 ug
    FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE PROPIONATE 100 ug
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63379-043-00 1 in 1 CARTON 02/28/2001
    1 60 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Approved Drug Product Manufactured Under Contract NDA021077 02/28/2001
    ADVAIR  DISKUS
    fluticasone propionate and salmeterol powder
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63379-044
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT) SALMETEROL 50 ug
    FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE PROPIONATE 250 ug
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63379-044-00 1 in 1 CARTON 02/05/2001
    1 60 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Approved Drug Product Manufactured Under Contract NDA021077 02/05/2001
    ADVAIR  DISKUS
    fluticasone propionate and salmeterol powder
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63379-045
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT) SALMETEROL 50 ug
    FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE PROPIONATE 500 ug
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63379-045-00 1 in 1 CARTON 03/05/2001
    1 60 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Approved Drug Product Manufactured Under Contract NDA021077 03/05/2001
    Labeler - Glaxo Operations UK Ltd (424738227)
    Close