NDC product

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

NDC 0121-0933 · PAI Holdings, LLC dba PAI Pharma

Key facts

Product NDC 0121-0933
Proprietary name Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Nonproprietary name Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Substances BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA202940
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
Marketing start Mar 3, 2022
Listing certified through Dec 31, 2026

At a glance

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Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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