Hydrocodone Bitartrate and Acetaminophen

Product NDC

68094-714

11-digit product format

680940714

Labeler code

68094

Product ID

68094-714_ec8d8161-cccb-48e8-91d5-be3df0dc3a5a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Acetaminophen

Dosage form

SOLUTION

Route

ORAL

Labeler

Precision Dose Inc.

Application

ANDA040894

Marketing category

ANDA

Marketing start

2014-02-27

Marketing end

2019-09-30

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

8 mg/15mL; mg/15mL

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