Xartemis

Product NDC

23635-115

11-digit product format

236350115

Labeler code

23635

Product ID

23635-115_07db75be-c9b9-425c-9024-f908a104ecfe

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

oxycodone hydrochloride and acetaminophen

Dosage form

TABLET, COATED

Route

ORAL

Labeler

SpecGx LLC

Application

NDA204031

Marketing category

NDA

Marketing start

2013-04-30

Marketing end

2019-05-31

Substance

OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN

Active strength

8 mg/1; 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