Nucynta

Product NDC

55700-555

11-digit product format

557000555

Labeler code

55700

Product ID

55700-555_f64b307c-c6d0-4746-a6f4-a955abfbfab6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

tapentadol hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC

Application

NDA200533

Marketing category

NDA

Marketing start

2017-06-16

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

2020-12-31

Current FDA listing

Historical FDA.report record