Hydrocodone Bitartrate and Acetaminophen

Product NDC

68084-884

11-digit product format

680840884

Labeler code

68084

Product ID

68084-884_7e012bbd-d4ca-7019-e053-2991aa0ab33e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

American Health Packaging

Application

ANDA040148

Marketing category

ANDA

Marketing start

2014-09-26

Marketing end

2019-11-30

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

10 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