Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Quality Care Products, LLC
Quality Care Products, LLC
831276758
Products4
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
55700-753Application 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: 25 ug in 1 h
FENTANYL
Product Details
NDC Product Code
55700-749Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 12 ug in 1 h
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
FENTANYL
Product Details
NDC Product Code
55700-748Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 50 ug in 1 h
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
FENTANYL
Product Details
NDC Product Code
55700-772Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
July 13, 2023POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 75 ug in 1 h