NUCYNTA

Product NDC

35356-593

11-digit product format

353560593

Labeler code

35356

Product ID

35356-593_af2e5bef-12cc-4964-8b85-8933b9ac634f

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

2011-07-13

Marketing end

0000-00-00

Substance

TAPENTADOL HYDROCHLORIDE

Active strength

75 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