Hydrocodone Bitartrate and Acetaminophen

Product NDC

47781-452

11-digit product format

477810452

Labeler code

47781

Product ID

47781-452_76fc4a85-a3b4-642d-8db3-957c12edf27f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate and Acetaminophen

Dosage form

TABLET

Route

ORAL

Labeler

Alvogen, Inc.

Application

ANDA209958

Marketing category

ANDA

Marketing start

2018-10-24

Marketing end

2021-12-31

Substance

HYDROCODONE BITARTRATE; ACETAMINOPHEN

Active strength

3 mg/1; mg/1

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