Quick answers
- What is Valrubicin Intravesical Solution?
- Valrubicin Intravesical Solution is a brand name of Valrubicin intravesical solution, a prescription medicine. The FDA NDC Directory lists 1 Valrubicin Intravesical Solution product in 1 strength and form.
- Who makes Valrubicin Intravesical Solution?
- Hikma holds the FDA application for Valrubicin Intravesical Solution (ANDA206430, approved April 19, 2019).
- Is there a generic or store brand of Valrubicin Intravesical Solution?
- Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Valrubicin Intravesical Solution product. Ask your pharmacist whether one is right for you.
- Has Valrubicin Intravesical Solution been recalled?
- No recall linked to Valrubicin Intravesical Solution products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Valrubicin Intravesical Solution is
Each Valrubicin Intravesical Solution 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.
Valrubicin intravesical solution · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| valrubicin 40 mg/mL solution, concentrate (intravesical) | Valrubicin Intravesical Solution | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Valrubicin intravesical solution →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA206430 | Hikma | April 19, 2019 | 1 |
Companies that list Valrubicin Intravesical Solution
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Valrubicin Intravesical Solution products.
- Hikma Pharmaceuticals USA Inc.1 product
Recalls
No recall linked to Valrubicin Intravesical Solution 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.