Fluticasone Propionate
These highlights do not include all the information needed to use Fluticasone Propionate Nasal Spray, USP safely and effectively. See full prescribing information for Fluticasone Propionate Nasal Spray, USP. Fluticasone Propionate Nasal Spray, USP, 50 mcg FOR INTRANASAL USE Initial U.S. Approval: 1994
Approved
Approval ID
5e1d9e90-fbe5-1ce9-e053-2a91aa0a89b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-4156
Application NumberANDA077570
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationNASAL
Effective DateFebruary 15, 2021
FDA Product Classification
INGREDIENTS (8)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 0.1 g
Code: O2GMZ0LF5W
Classification: ACTIB