Zyla Life Sciences US LLC
NDC labeler code: 69344
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
- Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 2 products
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product
- IndomethacinIndocin · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 17, 2011 | NDA202080 | Oxycodone hydrochloride OXAYDO | Zyla |
| May 14, 2010 | NDA022382 | Ketorolac tromethamine SPRIX | Cosette |
| October 10, 1985 | NDA018332 | Indomethacin INDOCIN | Cosette |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2023
-
October 20, 2023 · Class III · Ongoing · D-0094-2024 · Oxycodone hydrochloride
Sub-potent Drug: Lower potency than labeled.
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
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