Nucynta

Product NDC

50458-863

11-digit product format

504580863

Labeler code

50458

Product ID

50458-863_e4d6e211-2c12-4507-b371-610ee57379fa

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

tapentadol hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Janssen Pharmaceuticals, Inc.

Application

NDA200533

Marketing category

NDA

Marketing start

2011-08-25

Marketing end

2020-03-31

Substance

TAPENTADOL HYDROCHLORIDE

Active strength

200 mg/1

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record