Oxycodone and Acetaminophen

Product NDC

35356-937

11-digit product format

353560937

Labeler code

35356

Product ID

35356-937_8bb83d7a-4181-444e-9298-e32158529401

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Oxycodone and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA040778

Marketing category

ANDA

Marketing start

2007-11-27

Marketing end

0000-00-00

Substance

OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN

Active strength

10 mg/1; mg/1

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