Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl

Product NDC

60258-876

11-digit product format

602580876

Labeler code

60258

Product ID

60258-876_030d7689-e7e1-4698-8731-9a53c06bf074

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

hydrocodone bitartrate, chlorpheniramine maleate, pseudoephedrine hydrochloride

Dosage form

SOLUTION

Route

ORAL

Labeler

Cypress Pharmaceutical, Inc.

Application

NDA022439

Marketing category

NDA

Marketing start

2014-01-09

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