Fluticasone Propionate and Salmeterol
These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively. See full prescribing information for Fluticasone Propionate/Salmeterol DISKUS.Fluticasone Propionate/Salmeterol DISKUS inhalation powder, for oral inhalation useInitial U.S. Approval: 2000
Approved
Approval ID
b5dbe92c-9194-4000-92e4-cc933f242beb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 11, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 1
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 Code53002-1568
Application NumberNDA021077
Product Classification
M
Marketing Category
C73605
G
Generic Name
fluticasone propionate and salmeterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 7, 2019
FDA Product Classification
INGREDIENTS (3)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 100 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM