NDC 64597-301
Nuedexta 10 mg / 20 mg capsule, gelatin coated
On the label: Avanir Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Patheon Inc. | Mississauga, Canada | Makes it, packages it and labels it | Problems found, fixed voluntarilyFeb 24, 2023 · 7 inspections |
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: CFBFP
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dextromethorphan and Quinidine: every company that makes it
- Form
- capsule, gelatin coated, oral
- Strength
- 10 mg / 20 mg
- Approval
- NDA NDA021879
- On the market since
- Dec 1, 2010
- Package NDCs
64597-301-1364597-301-60- Official label
- DailyMed (National Library of Medicine), updated Oct 21, 2025
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