Oxymorphone hydrochloride

Product NDC

55700-417

11-digit product format

557000417

Labeler code

55700

Product ID

55700-417_fc4d1bf3-e56a-4c09-8b1d-d4d37852ac4c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Oxymorphone hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA079087

Marketing category

ANDA

Marketing start

2013-01-02

Marketing end

0000-00-00

Substance

OXYMORPHONE HYDROCHLORIDE

Active strength

15 mg/1

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record