NDC 47426-502
Zynrelef 9 mg per 10.5 mL / 300 mg per 10.5 mL solution
On the label: Heron Therapeutics, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apitoria Pharma Private Limited | Sangareddy, India | Makes the active ingredient | Problems found, fixed voluntarilySep 27, 2024 · 6 inspections |
| Cambrex Karlskoga AB | Karlskoga, Sweden | Makes the active ingredient | Problems found, fixed voluntarilyMay 24, 2024 · 5 inspections |
| Lifecore Biomedical, LLC | Chaska, MN, United States | Makes it | Problems found, fixed voluntarilyMar 12, 2025 · 4 inspections |
| Pharma Packaging Solutions, LLC | Clinton, TN, United States | Labels it | No problems foundJun 28, 2023 · 4 inspections |
Recalls
- Aug 2, 2022 · Class III · Heron Therapeutics, Inc.
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Lots: Lot #: 01126739, Exp 7/31/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bupivacaine and Meloxicam: every company that makes it
- Form
- solution
- Strength
- 9 mg per 10.5 mL / 300 mg per 10.5 mL
- Approval
- NDA NDA211988
- On the market since
- Dec 1, 2024
- Package NDCs
47426-502-0247426-502-04- Official label
- DailyMed (National Library of Medicine), updated Apr 20, 2026
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