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Advair Diskus

Generic Name: fluticasone propionate and salmeterol
Dosage Form: inhalation powder

Medically reviewed on February 1, 2018

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

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

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
fluticasone propionate and salmeterol powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60937-005
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALMETEROL XINAFOATE (SALMETEROL) SALMETEROL 50 ug
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 100 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM  
Packaging
# Item Code Package Description
1 NDC:60937-005-00 1 INHALER in 1 CARTON
1 60 POWDER in 1 INHALER
2 NDC:60937-005-01 1 INHALER in 1 CARTON
2 14 POWDER in 1 INHALER
3 NDC:60937-005-02 1 INHALER in 1 CARTON
3 14 POWDER in 1 INHALER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA021077 12/07/2017
ADVAIR  DISKUS
fluticasone propionate and salmeterol powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60937-006
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALMETEROL XINAFOATE (SALMETEROL) SALMETEROL 50 ug
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 250 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM  
Packaging
# Item Code Package Description
1 NDC:60937-006-00 1 INHALER in 1 CARTON
1 60 POWDER in 1 INHALER
2 NDC:60937-006-01 1 INHALER in 1 CARTON
2 14 POWDER in 1 INHALER
3 NDC:60937-006-02 1 INHALER in 1 CARTON
3 14 POWDER in 1 INHALER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA021077 12/07/2017
ADVAIR  DISKUS
fluticasone propionate and salmeterol powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60937-007
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALMETEROL XINAFOATE (SALMETEROL) SALMETEROL 50 ug
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 500 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM  
Packaging
# Item Code Package Description
1 NDC:60937-007-00 1 INHALER in 1 CARTON
1 60 POWDER in 1 INHALER
2 NDC:60937-007-01 1 INHALER in 1 CARTON
2 14 POWDER in 1 INHALER
3 NDC:60937-007-02 1 INHALER in 1 CARTON
3 14 POWDER in 1 INHALER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA021077 12/07/2017
Labeler - Glaxo Wellcome Production (383861593)
 
Glaxo Wellcome Production
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