NDC Code(s) : 66993-086-96, 66993-087-96, 66993-088-96
Packager : Prasco Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fluticasone Propionate and Salmeterol HFAfluticasone propionate and salmeterol xinafoate AEROSOL, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-086
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 PROPIONATE45 ug
SALMETEROL XINAFOATE(UNII: 6EW8Q962A5)
(SALMETEROL - UNII:2I4BC502BT) 		SALMETEROL21 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE(UNII: DH9E53K1Y8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-086-961 in 1 CARTON 03/01/2023
1120 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 NDA021254 03/01/2023
Fluticasone Propionate and Salmeterol HFAfluticasone propionate and salmeterol xinafoate AEROSOL, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-087
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 PROPIONATE115 ug
SALMETEROL XINAFOATE(UNII: 6EW8Q962A5)
(SALMETEROL - UNII:2I4BC502BT) 		SALMETEROL21 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE(UNII: DH9E53K1Y8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-087-961 in 1 CARTON 03/01/2023
1120 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 NDA021254 03/01/2023
Fluticasone Propionate and Salmeterol HFAfluticasone propionate and salmeterol xinafoate AEROSOL, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-088
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 PROPIONATE230 ug
SALMETEROL XINAFOATE(UNII: 6EW8Q962A5)
(SALMETEROL - UNII:2I4BC502BT) 		SALMETEROL21 ug
Inactive Ingredients
Ingredient Name Strength
NORFLURANE(UNII: DH9E53K1Y8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-088-961 in 1 CARTON 03/01/2023
1120 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 NDA021254 03/01/2023

LABELER - Prasco Laboratories(065969375)

REGISTRANT - GlaxoSmithKline LLC(167380711)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 66993-086-96

Fluticasone Propionate and Salmeterol HFA Inhalation Aerosol

45 mcg/21 mcg

PRASCO

For oral inhalation with Fluticasone Propionate and Salmeterol HFA actuator only.

Contents: Each canister contains a microcrystalline suspension of fluticasone propionate and salmeterol xinafoate in propellant HFA-134a (1,1,1,2-tetrafluoroethane).

Each actuation delivers 45 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece.

See prescribing information for dosage information.

RX Only

120 Metered Actuations

Net Wt. 12 g

  •  62000000083185 Rev. 10/22
Fluticasone Propionate and Salmeterol HFA 45 mcg-21 mcg 120 dose carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 66993-087-96

Fluticasone Propionate and Salmeterol HFA Inhalation Aerosol

115 mcg/21 mcg

PRASCO

For oral inhalation with Fluticasone Propionate and Salmeterol HFA actuator only.

Contents: Each canister contains a microcrystalline suspension of fluticasone propionate and salmeterol xinafoate in propellant HFA-134a (1,1,1,2-tetrafluoroethane).

Each actuation delivers 115 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece.

See prescribing information for dosage information.

RX Only

120 Metered Actuations

Net Wt. 12 g

  •  62000000083187 Rev. 10/22
Fluticasone Propionate and Salmeterol HFA 115 mcg-21 mcg 120 dose carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 66993-088-96

Fluticasone Propionate and Salmeterol HFA Inhalation Aerosol

230 mcg/21 mcg

PRASCO

For oral inhalation with Fluticasone Propionate and Salmeterol HFA actuator only.

Contents: Each canister contains a microcrystalline suspension of fluticasone propionate and salmeterol xinafoate in propellant HFA-134a (1,1,1,2-tetrafluoroethane).

Each actuation delivers 230 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece.

See prescribing information for dosage information.

RX Only

120 Metered Actuations

Net Wt. 12 g

  •  6200000083189 Rev. 10/22
Fluticasone Propionate and Salmeterol HFA 230 mcg-21 mcg 120 dose carton