OPANA

Product NDC

63481-612

11-digit product format

634810612

Labeler code

63481

Product ID

63481-612_73024db7-4992-42d4-96a0-50f6054a70e2

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Oxymorphone Hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

Endo Pharmaceuticals Inc.

Application

NDA021611

Marketing category

NDA

Marketing start

2006-06-26

Marketing end

2020-03-31

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