Hycet

Product NDC

0713-0703

11-digit product format

007130703

Labeler code

0713

Product ID

0713-0703_3bb57616-ce87-5a68-17d7-8dc7f2963a1f

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