oxycodone hydrochloride and acetaminophen

Product NDC

46672-648

11-digit product format

466720648

Labeler code

46672

Product ID

46672-648_acd5cd06-3d1b-f912-e053-2a95a90a73fa

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

oxycodone hydrochloride and acetaminophen

Dosage form

SOLUTION

Route

ORAL

Labeler

Mikart, LLC

Application

ANDA202142

Marketing category

ANDA

Marketing start

2018-03-20

Marketing end

0000-00-00

Substance

OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN

Active strength

10 mg/5mL; mg/5mL

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record