Oxycodone Hydrochloride

Product NDC

0054-0522

11-digit product format

000540522

Labeler code

0054

Product ID

0054-0522_db08764a-b691-4275-83d0-7dfd79e4896e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Oxycodone Hydrochloride

Dosage form

SOLUTION

Route

ORAL

Labeler

Roxane Laboratories, Inc.

Application

ANDA203208

Marketing category

ANDA

Marketing start

2013-07-16

Marketing end

0000-00-00

Substance

OXYCODONE HYDROCHLORIDE

Active strength

100 mg/5mL

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record