NDC 69452-478

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide 2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL syrup

On the label: Bionpharma Inc..

United States: 1India: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Brio Pharmaceuticals, IncHouston, TX, United StatesMakes it Problems found, fixed voluntarilyFeb 27, 2026 · 15 inspections
OrBion Pharmaceuticals Private LimitedKancheepuram, IndiaMakes it No problems foundOct 27, 2025 · 6 inspections

Product details

Generic drug
Brompheniramine and Dextromethorphan and Pseudoephedrine: every company that makes it
Form
syrup, oral
Strength
2 mg per 5 mL / 10 mg per 5 mL / 30 mg per 5 mL
Approval
ANDA ANDA203997
On the market since
Oct 1, 2025
Package NDCs
69452-478-55 69452-478-88
Official label
DailyMed (National Library of Medicine), updated Oct 1, 2025

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