Roxybond

Product NDC

65597-501

11-digit product format

655970501

Labeler code

65597

Product ID

65597-501_eb44aa7a-4db6-42ab-9141-8dbf3742be60

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

oxycodone hydrochloride

Dosage form

TABLET, COATED

Route

ORAL

Labeler

Daiichi Sankyo Inc.

Application

NDA209777

Marketing category

NDA

Marketing start

2017-04-20

Marketing end

0000-00-00

Substance

OXYCODONE 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

2020-12-31

Current FDA listing

Historical FDA.report record