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fluticasone propionate and salmeterol

These highlights do not include all the information needed to use FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE and SALMETEROL INHALATION POWDER.FLUTICASONE PROPIONATE and SALMETEROL inhalation powder, for oral inhalation useInitial U.S. Approval: 2000

Approved
Approval ID

f9fcfc90-3677-4a9b-900e-44417d50d507

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2023

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 080189610

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

fluticasone propionate and salmeterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-0326
Application NumberANDA203433
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluticasone propionate and salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2023
FDA Product Classification

INGREDIENTS (3)

SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM
FLUTICASONE PROPIONATEActive
Quantity: 100 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

fluticasone propionate and salmeterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-0327
Application NumberANDA203433
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluticasone propionate and salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2023
FDA Product Classification

INGREDIENTS (3)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM
FLUTICASONE PROPIONATEActive
Quantity: 250 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB

fluticasone propionate and salmeterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-0328
Application NumberANDA203433
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluticasone propionate and salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2023
FDA Product Classification

INGREDIENTS (3)

FLUTICASONE PROPIONATEActive
Quantity: 500 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM

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fluticasone propionate and salmeterol - FDA Drug Approval Details