Hydrocodone Bitartrate And Acetaminophen

Product NDC

51079-777

11-digit product format

510790777

Labeler code

51079

Product ID

51079-777_7df4ab0a-db4d-8291-e053-2991aa0a3043

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate And Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA040655

Marketing category

ANDA

Marketing start

2007-09-10

Marketing end

0000-00-00

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

5 mg/1; mg/1

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