Abstral

Product NDC

42358-300

11-digit product format

423580300

Labeler code

42358

Product ID

42358-300_a5edb551-b75b-4930-b557-1a3f1aa5115c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

fentanyl citrate

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

SUBLINGUAL

Labeler

Sentynl Therapeutics, Inc.

Application

NDA022510

Marketing category

NDA

Marketing start

2016-10-01

Marketing end

0000-00-00

Substance

FENTANYL CITRATE

Active strength

300 ug/1

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