Opana

Product NDC

63481-812

11-digit product format

634810812

Labeler code

63481

Product ID

63481-812_a9737e83-4dc5-4189-9100-dd1612d83191

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

2020-02-01

Substance

OXYMORPHONE HYDROCHLORIDE

Active strength

5 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