Quick answers
- What is Cevimeline hydrochloride used for?
- The FDA-approved label (Evoxac, Cosette Pharmaceuticals, Inc., September 7, 2022) says: “Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cevimeline hydrochloride have a boxed warning?
- No. None of the 20 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cevimeline hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cevimeline hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cevimeline hydrochloride?
- 15 companies list prescription products of Cevimeline hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Cosette Pharmaceuticals, Inc. and Hikma Pharmaceuticals USA Inc..
What Cevimeline hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
— FDA label: Evoxac, Cosette Pharmaceuticals, Inc., effective September 7, 2022. Read the full label on DailyMed →
The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 22 in the FDA NDC Directory |
| Brand names | Evoxac |
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 |
|---|---|---|
| cevimeline hydrochloride 30 mg capsule | Generic | $0.7240 per capsule |
| cevimeline hydrochloride 30 mg capsule | Brand: Evoxac | $8.59 per capsule |
NADAC list of November 4, 2026; these prices took effect between July 1, 2026 and 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 this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack5 products
- Cosette Pharmaceuticals, Inc.2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Asclemed USA, Inc.2 products
- PD-Rx Pharmaceuticals, Inc.1 product
- Novel Laboratories, Inc.1 product
- Lupin Pharmaceuticals, Inc.1 product
- Zydus Lifesciences Limited1 product
- Aurobindo Pharma Limited1 product
- Macleods Pharmaceuticals Limited1 product
- Advagen Pharma Ltd1 product
- Bionpharma Inc.1 product
- Viona Pharmaceuticals Inc1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Rising Pharma Holdings, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020989 EVOXAC | Cosette | January 11, 2000 | 7, latest November 1, 2013 2013: Manufacturing (CMC) · 2006: Labeling · 2005: Labeling |
Generic approvals (8)
- ANDA091591Hikma · July 8, 2013
- ANDA203775Rising · June 4, 2014
- ANDA204746Novel Labs Inc · December 30, 2016
- ANDA216682Rubicon Research · April 6, 2023
- ANDA215056Aurobindo Pharma · April 18, 2023
- ANDA218290Bionpharma · November 8, 2023
- ANDA206808Macleods Pharms · September 20, 2024
- ANDA220267Zydus Lifesciences · March 11, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 261361, 309140 |
|---|---|
| SPL set ID of the quoted label | dac32a9b-05b8-42c2-9a29-d885a9279456 |
| FDA labels (SPL) | 20 |
| FDA applications | NDA020989, 8 ANDA |
| Active ingredients (FDA) | CEVIMELINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Evoxac, Cosette Pharmaceuticals, Inc., effective September 7, 2022; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →