NUCYNTA

Product NDC

35356-611

11-digit product format

353560611

Labeler code

35356

Product ID

35356-611_e51890f2-dee6-42e7-9f8f-546865922a8d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

tapentadol hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

NDA022304

Marketing category

NDA

Marketing start

2009-06-01

Marketing end

0000-00-00

Substance

TAPENTADOL HYDROCHLORIDE

Active strength

100 mg/1

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record