Quick answers
- What is Saphris?
- Saphris is a brand name of Asenapine, a prescription medicine. The FDA NDC Directory lists 3 Saphris products in 3 strengths and forms.
- Who makes Saphris?
- Abbvie holds the FDA application for Saphris (NDA022117, approved August 13, 2009).
- Is there a generic or store brand of Saphris?
- Yes. The FDA NDC Directory lists 10 other products with the same active ingredients, strength and form as a Saphris product, 10 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Saphris?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 3 Saphris strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Saphris been recalled?
- FDA enforcement reports list 1 recall of Saphris products; the newest started May 18, 2017. A recall usually concerns specific lots, not every product.
What Saphris is
Each Saphris 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.
Asenapine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| asenapine maleate 10 mg tablet (sublingual) | Saphris | 4 products, 2 companies | DailyMed |
| asenapine maleate 2.5 mg tablet (sublingual) | Saphris | 2 products, 2 companies | DailyMed |
| asenapine maleate 5 mg tablet (sublingual) | Saphris | 4 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Asenapine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022117 | Abbvie | August 13, 2009 | 3 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| asenapine maleate 10 mg tablet | Brand: Saphris | $21.18 per tablet Generic of the same strength and form: $2.36 per tablet |
| asenapine maleate 2.5 mg tablet | Brand: Saphris | $21.00 per tablet Generic of the same strength and form: $3.10 per tablet |
| asenapine maleate 5 mg tablet | Brand: Saphris | $21.16 per tablet Generic of the same strength and form: $2.09 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Saphris
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Saphris products.
- Allergan, Inc.3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 18, 2017 · Class II · Terminated · D-0880-2017
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent UK Swindon, Zydis Ltd, Blagrove, Swindon, Wilshire SN5 BRU, UK Distributed by Forest Pharmac — Forest Laboratories, LLC
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.