Hydrocodone Bitartrate and Acetaminophen

Product NDC

42291-332

11-digit product format

422910332

Labeler code

42291

Product ID

42291-332_9c5d4741-9b7d-33df-e053-2a95a90a6a9e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA040736

Marketing category

ANDA

Marketing start

2016-09-06

Marketing end

0000-00-00

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

2021-12-31

Current FDA listing

Historical FDA.report record