Quick answers
- What is Sprix?
- Sprix is a brand name of Ketorolac tromethamine, a prescription medicine. The FDA NDC Directory lists 1 Sprix product in 1 strength and form.
- Who makes Sprix?
- Cosette holds the FDA application for Sprix (NDA022382, approved May 14, 2010).
- Is there a generic or store brand of Sprix?
- Other products of Ketorolac tromethamine are listed with the FDA, but none in exactly the same strength and form as a Sprix product.
- Has Sprix been recalled?
- No recall linked to Sprix products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Sprix is
Each Sprix product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Ketorolac tromethamine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ketorolac tromethamine 15.75 mg spray, metered (nasal) | Sprix | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ketorolac tromethamine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022382 | Cosette | May 14, 2010 | 1 |
Companies that list Sprix
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Sprix products.
- Zyla Life Sciences US LLC1 product
Recalls
No recall linked to Sprix products (by their NDC code or label) appears in the FDA enforcement reports.
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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.