Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride

Product NDC

0574-1103

11-digit product format

005741103

Labeler code

0574

Product ID

0574-1103_766fa673-6f1b-4731-b025-551c1c862c60

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride

Dosage form

SOLUTION

Route

ORAL

Labeler

Paddock Laboratories, LLC

Application

ANDA204627

Marketing category

ANDA

Marketing start

2014-08-26

Marketing end

2019-10-31

Substance

HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Active strength

5 mg/5mL; mg/5mL; mg/5mL

Pharmacologic classes

Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]

DEA schedule

CII

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record