ZUTRIPRO

Product NDC

63717-876

11-digit product format

637170876

Labeler code

63717

Product ID

63717-876_4ed25d38-27e1-4ee4-92b5-d3af4dbac6be

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride

Dosage form

SOLUTION

Route

ORAL

Labeler

Hawthorn Pharmaceuticals, Inc.

Application

NDA022439

Marketing category

NDA

Marketing start

2011-06-08

Marketing end

0000-00-00

Substance

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE

Active strength

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

Pharmacologic classes

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

DEA schedule

CII

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record