NDC 53002-2279
Azelastine Hydrochloride 137 ug spray, metered
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 47335-779.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · relabels it
Recalls
- Feb 5, 2018 · Class III · Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Lots: JKR7706A December 2018 JKR7705A November 2018
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Azelastine: every company that makes it
- Form
- spray, metered
- Strength
- 137 ug
- Approval
- ANDA ANDA090423
- On the market since
- May 24, 2012
- Package NDCs
53002-2279-1- Official label
- DailyMed (National Library of Medicine), updated Mar 30, 2022
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