Hydrocodone Bitartrate and Acetaminophen

Product NDC

51862-228

11-digit product format

518620228

Labeler code

51862

Product ID

51862-228_134b9831-bb50-4720-8e11-61aa70cb06ab

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Mayne Pharma Inc.

Application

ANDA090118

Marketing category

ANDA

Marketing start

2014-04-01

Marketing end

2020-06-30

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

8 mg/1; mg/1

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record