DURAGESIC

Product NDC

50458-091

11-digit product format

504580091

Labeler code

50458

Product ID

50458-091_b9ea67cc-7dc9-11e8-99c1-0e91676ff592

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

fentanyl

Dosage form

PATCH

Route

TRANSDERMAL

Labeler

Janssen Pharmaceuticals, Inc.

Application

NDA019813

Marketing category

NDA

Marketing start

1990-08-07

Marketing end

2019-10-31

Substance

FENTANYL

Active strength

25 ug/h

Pharmacologic classes

Full Opioid Agonists [MoA],Opioid Agonist [EPC]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record