Hydrocodone Bitartrate and Acetaminophen

Product NDC

64950-340

11-digit product format

649500340

Labeler code

64950

Product ID

64950-340_37133980-bcf2-4b2f-95dc-39c2fa91f0bc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Acetaminophen

Dosage form

SOLUTION

Route

ORAL

Labeler

Genus Lifesciences Inc.

Application

ANDA200343

Marketing category

ANDA

Marketing start

2014-04-01

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