FLUTICASONE
FLUTICASONE PROPIONATE SPRAY
Approved
Approval ID
ab7529ac-fa19-4be8-9906-8889fa3e8398
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 9, 2019
Manufacturers
FDA
Direct RX
DUNS: 079254320
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FLUTICASONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-611
Application NumberANDA076504
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUTICASONE
Product Specifications
Route of AdministrationNASAL
Effective DateApril 9, 2019
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
FLUTICASONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-004
Application NumberANDA078492
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUTICASONE
Product Specifications
Route of AdministrationNASAL
Effective DateApril 9, 2019
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OK
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
FLUTICASONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-620
Application NumberANDA077570
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUTICASONE
Product Specifications
Route of AdministrationNASAL
Effective DateApril 9, 2019
FDA Product Classification
INGREDIENTS (8)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 0.1 g
Code: O2GMZ0LF5W
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT