NDC Code(s) : 66993-584-97, 66993-585-97, 66993-586-97
Packager : Prasco Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fluticasone Propionate and Salmeterol fluticasone propionate and salmeterol POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-584
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE(UNII: O2GMZ0LF5W)
(FLUTICASONE - UNII:CUT2W21N7U) 		FLUTICASONE PROPIONATE100 ug
SALMETEROL XINAFOATE(UNII: 6EW8Q962A5)
(SALMETEROL - UNII:2I4BC502BT) 		SALMETEROL50 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-584-971 in 1 CARTON 02/08/2019
160 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
NDA authorized generic NDA021077 02/08/2019
Fluticasone Propionate and Salmeterol fluticasone propionate and salmeterol POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-585
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE(UNII: O2GMZ0LF5W)
(FLUTICASONE - UNII:CUT2W21N7U) 		FLUTICASONE PROPIONATE250 ug
SALMETEROL XINAFOATE(UNII: 6EW8Q962A5)
(SALMETEROL - UNII:2I4BC502BT) 		SALMETEROL50 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-585-971 in 1 CARTON 02/08/2019
160 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
NDA authorized generic NDA021077 02/08/2019
Fluticasone Propionate and Salmeterol fluticasone propionate and salmeterol POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-586
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUTICASONE PROPIONATE(UNII: O2GMZ0LF5W)
(FLUTICASONE - UNII:CUT2W21N7U) 		FLUTICASONE PROPIONATE500 ug
SALMETEROL XINAFOATE(UNII: 6EW8Q962A5)
(SALMETEROL - UNII:2I4BC502BT) 		SALMETEROL50 ug
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-586-971 in 1 CARTON 02/08/2019
160 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
NDA authorized generic NDA021077 02/08/2019

LABELER - Prasco Laboratories(065969375)

REGISTRANT - GlaxoSmithKline LLC(167380711)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 66993-584-97

Fluticasone Propionate/Salmeterol DISKUS Inhalation Powder

100 mcg/50 mcg

PRASCO

Rx Only

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.

1 DISKUS Inhalation Device

Containing 1 Foil Strip of 60 Blisters

  •  62000000078061 Rev. 4/22
Fluticasone Propionate - Salmeterol Diskus 100-50 mcg carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 66993-585-97

Fluticasone Propionate/Salmeterol DISKUS Inhalation Powder

250 mcg/50 mcg

PRASCO

Rx Only

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.

1 DISKUS Inhalation Device

Containing 1 Foil Strip of 60 Blisters

  •  62000000078059 Rev. 4/22
Fluticasone Propionate - Salmeterol Diskus 250-50 mcg carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 66993-586-97

Fluticasone Propionate/Salmeterol DISKUS Inhalation Powder

500 mcg /50 mcg

PRASCO

Rx Only

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.

1 DISKUS Inhalation Device

Containing 1 Foil Strip of 60 Blisters

  •  62000000078060 Rev. 4/22
Fluticasone Propionate - Salmeterol Diskus 500-50 mcg carton