Fluticasone Propionate
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE NASAL SPRAY safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE NASAL SPRAY. FLUTICASONE PROPIONATE nasal spray Initial U.S. Approval: 1994
Approved
Approval ID
6e2d11f9-94d8-4434-b46b-8e2fcc9276fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2025
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluticasone Propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76420-329
Application NumberANDA076504
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationNASAL
Effective DateApril 19, 2025
FDA Product Classification
INGREDIENTS (7)
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB