Hydrocodone Bitartrate and Acetaminophen

Product NDC

0904-6567

11-digit product format

009046567

Labeler code

0904

Product ID

0904-6567_1e958ac1-72a6-4849-9f88-7200c6432210

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Major Pharmaceuticals

Application

ANDA040148

Marketing category

ANDA

Marketing start

2016-05-26

Marketing end

2019-12-31

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

5 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