Opana ER

Product NDC

63629-4174

11-digit product format

636294174

Labeler code

63629

Product ID

63629-4174_b0d683e0-ee2e-4a82-8ae5-fec301c8167b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

OXYMORPHONE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

NDA021610

Marketing category

NDA

Marketing start

2010-12-31

Marketing end

0000-00-00

Substance

OXYMORPHONE HYDROCHLORIDE

Active strength

20 mg/1

Pharmacologic classes

Full Opioid Agonists [MoA],Opioid Agonist [EPC]

DEA schedule

CII

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record