Opana

Product NDC

63481-813

11-digit product format

634810813

Labeler code

63481

Product ID

63481-813_78824d02-9c7b-45ce-8030-48bc1d817cc6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

oxymorphone hydrochloride

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Endo Pharmaceuticals, Inc.

Application

NDA201655

Marketing category

NDA

Marketing start

2012-03-20

Marketing end

2019-08-01

Substance

OXYMORPHONE HYDROCHLORIDE

Active strength

8 mg/1

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record