HYDROCODONE/APAP

Product NDC

54348-013

11-digit product format

543480013

Labeler code

54348

Product ID

54348-013_47c0f6e2-91e1-42d2-9fce-c74799ac3109

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

HYDROCODONE BITARTRATE,

Dosage form

TABLET

Route

ORAL

Labeler

PharmPak, Inc.

Application

ANDA040099

Marketing category

ANDA

Marketing start

2014-09-01

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