Hydrocodone Bitartrate and Acetaminophen

Product NDC

0591-2172

11-digit product format

005912172

Labeler code

0591

Product ID

0591-2172_1e4c7b2c-26c4-4ab7-a586-42809be22140

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Actavis Pharma, Inc.

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