Quick answers
- What is Avalide?
- Avalide is a brand name of Irbesartan and hydrochlorothiazide, a prescription medicine. The FDA NDC Directory lists 2 Avalide products in 2 strengths and forms.
- Who makes Avalide?
- Sanofi Aventis US holds the FDA application for Avalide (NDA020758, approved September 30, 1997).
- Is there a generic or store brand of Avalide?
- Yes. The FDA NDC Directory lists 13 other products with the same active ingredients, strength and form as a Avalide product, 13 of them generic. Ask your pharmacist whether one is right for you.
- Has Avalide been recalled?
- No recall linked to Avalide products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Avalide is
Each Avalide 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.
Irbesartan and hydrochlorothiazide · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| hydrochlorothiazide 12.5 mg · irbesartan 150 mg tablet, film coated (oral) | Avalide | 9 products, 6 companies | DailyMed |
| hydrochlorothiazide 12.5 mg · irbesartan 300 mg tablet, film coated (oral) | Avalide | 4 products, 4 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Irbesartan and hydrochlorothiazide →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020758 | Sanofi Aventis US | September 30, 1997 | 2 |
Companies that list Avalide
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Avalide products.
- Sanofi-Aventis U.S. LLC2 products
Recalls
No recall linked to Avalide 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.