Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
DirectRX
DirectRX
079254320
Products1
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
61919-602Application Number
ANDA077449Marketing Category
ANDA (C73584)Route of Administration
TRANSDERMALEffective Date
January 20, 2020POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7Class: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYISOBUTYLENE (800000 MW)Inactive
Code: Y132ZOQ9H7Class: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 25 ug in 1 h