Opana

Product NDC

35356-848

11-digit product format

353560848

Labeler code

35356

Product ID

35356-848_c0d14e51-b521-45ca-af3f-667af6f27f23

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

oxymorphone hydrochloride

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

NDA201655

Marketing category

NDA

Marketing start

2012-03-20

Marketing end

0000-00-00

Substance

OXYMORPHONE HYDROCHLORIDE

Active strength

40 mg/1

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record