BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE

Product NDC

64376-657

11-digit product format

643760657

Labeler code

64376

Product ID

64376-657_8cd470bd-4f3a-4ac9-8b21-3106daec0c9f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE

Dosage form

SYRUP

Route

ORAL

Labeler

Par Pharmaceutical

Application

ANDA202940

Marketing category

ANDA

Marketing start

2014-07-21

Marketing end

2020-10-31

Substance

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Active strength

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

Pharmacologic classes

Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record