Heron Therapeutics, Inc.
NDC labeler code: 47426
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Bupivacaine and meloxicamZynrelef · 2 products
- AprepitantEmend, Cinvanti, Aponvie · 2 products
- GranisetronGranisol, Sancuso, Sustol · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 16, 2022 | NDA216457 | Aprepitant APONVIE | Heron Theraps Inc |
| May 12, 2021 | NDA211988 | Bupivacaine and meloxicam ZYNRELEF KIT | Heron Theraps Inc |
| November 9, 2017 | NDA209296 | Aprepitant CINVANTI | Heron Theraps Inc |
| August 9, 2016 | NDA022445 | Granisetron SUSTOL | Heron Theraps Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2022
-
August 2, 2022 · Class III · Terminated · D-1335-2022 · Bupivacaine and meloxicam
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026