Hydrocodone Bitartrate and Acetaminophen

Product NDC

0713-0704

11-digit product format

007130704

Labeler code

0713

Product ID

0713-0704_7068bb40-bcc8-1d45-09e7-5dac7f01fe4a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone bitartrate and acetaminophen

Dosage form

SOLUTION

Route

ORAL

Labeler

G&W Laboratories, Inc.

Application

ANDA040482

Marketing category

ANDA

Marketing start

2011-02-01

Marketing end

0000-00-00

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

2019-12-31

Current FDA listing

Historical FDA.report record