FENTANYL TRANSDERMAL SYSTEM

Product NDC

35356-638

11-digit product format

353560638

Labeler code

35356

Product ID

35356-638_ad219a3b-82d1-4eca-94c0-e2ecb5e08823

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

fentanyl transdermal system

Dosage form

PATCH, EXTENDED RELEASE

Route

TRANSDERMAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA077154

Marketing category

ANDA

Marketing start

2011-06-06

Marketing end

0000-00-00

Substance

FENTANYL

Active strength

75 ug/h

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record