Prescription medicine
Cevimeline Brand names: Evoxac
Cevimeline (Evoxac) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $0.729 per cevimeline HCl 30 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cevimeline FDA label on DailyMed (effective January 5, 2023, Cosette Pharmaceuticals, Inc.); the NDA 20989 record on Drugs@FDA; every cevimeline label on DailyMed.
Highlights of the record
FDA label of January 5, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
Forms and strengths
- 30 mg
Capsule.
On the market
- Earliest approval on file
- January 11, 2000 Evoxac, Cosette; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first August 25, 2011; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 13 under generic applications, 4 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.729 per capsule Cevimeline HCl 30 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2015 0 Class I among all firms' recalls; latest August 17, 2015
- FAERS reports
- 2,694 through July 30, 2026
What is cevimeline used for?
From the label: indications and usageCevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
FDA pharmacologic class: Cholinergic Receptor Agonist.
Source: FDA drug label (cevimeline hydrochloride), Cosette Pharmaceuticals, Inc., effective January 5, 2023 (SPL set efc2bb24-4dda-4781-bef5-fcd9abf082dd), via openFDA; the full label on DailyMed
Is there a generic for cevimeline (Evoxac)?
The FDA approved the first generic cevimeline on August 25, 2011. 9 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cevimeline from 13 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2000 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cevimeline (Evoxac)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.729 per Cevimeline HCl 30 mg capsule, up 3% from $0.707 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cevimeline HCl 30 mg capsule (generic)
- Evoxac 30 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cevimeline HCl 30 mg capsule | Generic | $0.729 per capsule | $21.87 | +3% |
| Evoxac 30 mg capsule | Brand | $8.59 per capsule | $257.73 | +11% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cevimeline been recalled?
The FDA's Enforcement Report lists 1 recall naming cevimeline since 2015: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 17, 2015 | Class II | Apotex Inc. | Failed Stability Specifications: product may not meet specification limit for assay test. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for cevimeline?
The FDA Adverse Event Reporting System holds 2,694 reports that list cevimeline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 105 are coded as a death and 660 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cholinergic receptor agonists
- the pharmacologic class, with prices and generics
- Cevimeline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other