OXYMORPHONE HYDROCHLORIDE

Product NDC

0406-1009

11-digit product format

004061009

Labeler code

0406

Product ID

0406-1009_0c2957c6-5714-416c-9afb-98ee965950f7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Oxymorphone Hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

SpecGx LLC

Application

ANDA202321

Marketing category

ANDA

Marketing start

2013-04-25

Marketing end

2021-01-31

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