Oxycodone and Acetaminophen

Product NDC

68094-013

11-digit product format

680940013

Labeler code

68094

Product ID

68094-013_87a2f2ae-2539-4cb2-9067-0838e5a273ca

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Oxycodone Hydrochloride and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Precision Dose, Inc.

Application

ANDA040777

Marketing category

ANDA

Marketing start

2017-07-31

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

2019-12-31

Current FDA listing

Historical FDA.report record