Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aveva Drug Delivery Systems Inc.
Apotex Corp.
783982093
Products12
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
60505-7015Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 37.5 ug in 1 h
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
FENTANYL
Product Details
NDC Product Code
60505-7007Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 50 ug in 1 h
FENTANYL
Product Details
NDC Product Code
60505-7011Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 25 ug in 1 h
FENTANYL
Product Details
NDC Product Code
60505-7006Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 25 ug in 1 h
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
FENTANYL
Product Details
NDC Product Code
60505-7013Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 75 ug in 1 h
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
FENTANYL
Product Details
NDC Product Code
60505-7016Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 62.5 ug in 1 h
FENTANYL
Product Details
NDC Product Code
60505-7008Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 75 ug in 1 h
FENTANYL
Product Details
NDC Product Code
60505-7009Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 100 ug in 1 h
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
FENTANYL
Product Details
NDC Product Code
60505-7010Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 12 ug in 1 h
FENTANYL
Product Details
NDC Product Code
60505-7017Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 87.5 ug in 1 h
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
Showing 1 to 10 of 12 products
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
RECENT MAJOR CHANGES SECTION
Highlight: Dosage and Administration ( 2) 1/2018
Boxed Warning 09/2018
Warnings and Precautions ( 5.2) 09/2019
RECENT MAJOR CHANGES
Dosage and Administration ( 2) 1/2018
Boxed Warning 09/2018
Warnings and Precautions ( 5.2) 09/2019