Oxycodone and Acetaminophen

Product NDC

68308-405

11-digit product format

683080405

Labeler code

68308

Product ID

68308-405_293f94a6-c786-401e-9c0e-70aee4b40955

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Oxycodone Hydrochloride and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Mayne Pharma Inc.

Application

ANDA090177

Marketing category

ANDA

Marketing start

2008-12-16

Marketing end

0000-00-00

Substance

OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN

Active strength

5 mg/1; 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