ADVAIR DISKUS- fluticasone propionate and salmeterol powder
Glaxo Wellcome Production

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Advair diskus manufacturer

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

: 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

: 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

: 10000000142021 Rev. 7/16

ADVAIR DISKUS
fluticasone propionate and salmeterol powder

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:60937-005
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)	SALMETEROL	50 ug
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)	FLUTICASONE PROPIONATE	100 ug

Ingredient Name	Strength
Inactive Ingredients
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60937-005-00	1 in 1 CARTON	12/07/2017
1		60 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:60937-005-01	1 in 1 CARTON	12/07/2017
2		14 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC:60937-005-02	1 in 1 CARTON	12/07/2017
3		14 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA021077	12/07/2017

ADVAIR DISKUS
fluticasone propionate and salmeterol powder

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:60937-006
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)	SALMETEROL	50 ug
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)	FLUTICASONE PROPIONATE	250 ug

Ingredient Name	Strength
Inactive Ingredients
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60937-006-00	1 in 1 CARTON	12/07/2017
1		60 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:60937-006-01	1 in 1 CARTON	12/07/2017
2		14 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC:60937-006-02	1 in 1 CARTON	12/07/2017
3		14 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA021077	12/07/2017

ADVAIR DISKUS
fluticasone propionate and salmeterol powder

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:60937-007
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALMETEROL XINAFOATE (UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)	SALMETEROL	50 ug
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)	FLUTICASONE PROPIONATE	500 ug

Ingredient Name	Strength
Inactive Ingredients
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60937-007-00	1 in 1 CARTON	12/07/2017
1		60 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC:60937-007-01	1 in 1 CARTON	12/07/2017
2		14 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC:60937-007-02	1 in 1 CARTON	12/07/2017
3		14 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA021077	12/07/2017

Labeler - Glaxo Wellcome Production (383861593)

Revised: 2/2018

Document Id: 1ae9d924-e047-40ac-97e4-595a427b547f

Set id: 1ae9d924-e047-40ac-97e4-595a427b547f

Version: 1

Effective Time: 20180207

Glaxo Wellcome Production