NDC 70954-912
Hydroxyzine Hydrochloride 10 mg per 5 mL solution
On the label: ANI Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novitium Pharma LLC | East Windsor, NJ, United States | Makes it, tests it, packages it and labels it | No problems foundFeb 16, 2024 · 5 inspections |
Recalls
- Jun 2, 2026 · Class III · ANI Pharmaceuticals, Inc.
Presence of foreign substance
Lots: Lot S25133A
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydroxyzine: every company that makes it
- Form
- solution, oral
- Strength
- 10 mg per 5 mL
- Approval
- ANDA ANDA219648
- On the market since
- Jan 15, 2026
- Package NDCs
70954-912-10- Official label
- DailyMed (National Library of Medicine), updated Feb 11, 2025
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