Products8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FENTANYL
Product Details
NDC Product Code
0378-9123Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
April 13, 2023FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 75 ug in 1 h
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3HClass: IACT
FENTANYL
Product Details
NDC Product Code
0378-9127Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
April 13, 2023FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 87.5 ug in 1 h
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3HClass: IACT
FENTANYL
Product Details
NDC Product Code
0378-9121Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
April 13, 2023FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 25 ug in 1 h
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3HClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FENTANYL
Product Details
NDC Product Code
0378-9126Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
April 13, 2023DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 62.5 ug in 1 h
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3HClass: IACT
FENTANYL
Product Details
NDC Product Code
0378-9119Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
April 13, 2023TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3HClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 12 ug in 1 h
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FENTANYL
Product Details
NDC Product Code
0378-9122Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
April 13, 2023FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 50 ug in 1 h
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3HClass: IACT
FENTANYL
Product Details
NDC Product Code
0378-9124Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
April 13, 2023FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 100 ug in 1 h
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3HClass: IACT
FENTANYL
Product Details
NDC Product Code
0378-9125Application Number
ANDA076258Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
April 13, 2023DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 37.5 ug in 1 h
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 5000000 PA.S)Inactive
Code: 9N5G1G3D3HClass: IACT