Quick answers
- What is Remeronsoltab?
- Remeronsoltab is a brand name of Mirtazapine, a prescription medicine. The FDA NDC Directory lists 3 Remeronsoltab products in 3 strengths and forms.
- Who makes Remeronsoltab?
- Organon USA Organon holds the FDA application for Remeronsoltab (NDA021208, approved January 12, 2001).
- Is there a generic or store brand of Remeronsoltab?
- Yes. The FDA NDC Directory lists 15 other products with the same active ingredients, strength and form as a Remeronsoltab product, 15 of them generic. Ask your pharmacist whether one is right for you.
- Has Remeronsoltab been recalled?
- No recall linked to Remeronsoltab products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Remeronsoltab is
Each Remeronsoltab 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.
Mirtazapine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| mirtazapine 15 mg tablet, orally disintegrating (oral) | Remeronsoltab | 5 products, 5 companies | DailyMed |
| mirtazapine 30 mg tablet, orally disintegrating (oral) | Remeronsoltab | 6 products, 5 companies | DailyMed |
| mirtazapine 45 mg tablet, orally disintegrating (oral) | Remeronsoltab | 4 products, 4 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Mirtazapine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021208 | Organon USA Organon | January 12, 2001 | 3 |
Companies that list Remeronsoltab
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Remeronsoltab products.
- Organon LLC3 products
Recalls
No recall linked to Remeronsoltab 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.