Thea Pharma Inc.
NDC labeler code: 82584
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
- Dorzolamide hydrochloride and timolol maleateCosopt, Dorzolamide Hydrochloride Timolol Maletae, Cosopt Pf · 2 products
- TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 2 products
- LatanoprostIyuzeh, Xalatan, Xelpros · 1 product
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 1 product
- AzithromycinZithromax, Azasite · 1 product
- BimatoprostLumigan, Latisse, Durysta · 1 product
- TafluprostZioptan · 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 9, 2025 | NDA217307 | Bimatoprost ZOLYMBUS | Thea Pharma |
| December 13, 2022 | NDA216472 | Latanoprost IYUZEH | Thea Pharma |
| February 10, 2012 | NDA202514 | Tafluprost ZIOPTAN | Thea Pharma |
| February 1, 2012 | NDA202667 | Dorzolamide hydrochloride and timolol maleate COSOPT PF | Thea Pharma |
| October 7, 2008 | NDA022221 | Lidocaine AKTEN | Thea Pharma |
| April 27, 2007 | NDA050810 | Azithromycin AZASITE | Thea Pharma |
| April 7, 1998 | NDA020869 | Dorzolamide hydrochloride and timolol maleate COSOPT | Thea Pharma |
| March 31, 1995 | NDA020439 | Timolol BETIMOL | Thea Pharma |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
March 5, 2024 · Class II · Terminated · D-0374-2024 · Timolol
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
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
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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