Abstral

Product NDC

42358-800

11-digit product format

423580800

Labeler code

42358

Product ID

42358-800_c6673375-386d-4fbe-ab79-1dd5c9a7c915

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

2020-06-30

Substance

FENTANYL CITRATE

Active strength

800 ug/1

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