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Cevimeline 30 mg Capsule, 100-count — NDC 69452-316-20 (Billing 69452-0316-20)

by Bionpharma Inc · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Cevimeline 30 mg Capsule from Bionpharma Inc, marketed since Jan 2024 and currently FDA-listed; retail pharmacies pay about $0.7289 per capsule (NADAC). It is this product's only package size.

NDC 69452-0316-20
🏷️ FDA NDC (as labeled) 69452-316-20 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69452-316-20
Product NDC 69452-316
11-digit billing NDC 69452031620
NCPDP billing unit EA — each (per item)
RxCUI 309140
UNII P81Q6V85NP
Application # ANDA218290
SPL Set ID 0f15cb50-5917-c928-e063-6294a90ab284
Established class (EPC) Cholinergic Receptor Agonist
Mechanism of action Cholinergic Muscarinic Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-17
Route ORAL
Dosage form CAPSULE
Substance CEVIMELINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 88501525100120
GCN Seq No 044913
GCN 12624
HICL code 021080
Ingredient (HICL) Cevimeline Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J1
Therapeutic class — intermediate (HIC2) Cholinergics
HIC3 code J1A
Therapeutic class — specific (HIC3) Parasympathetic Agents
AHFS code 12:04.00.00
AHFS class Parasympathomimetic (Cholinergic Agents)
FDB label name CEVIMELINE HCL 30 MG CAPSULE
FDB brand name Cevimeline Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 044913
  • GCN: 12624
  • GPI-14 (Medi-Span): 88501525100120
  • HICL (First Databank): 021080
  • AHFS class code: 12:04.00.00
  • RxCUI (RxNorm): 309140
Why two NDCs? The FDA registers this code as 69452-316-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69452-0316-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cholinergic Receptor Agonist class.

Pharmacologic class Cholinergic Receptor Agonist
Drug family (ATC) Other parasympathomimetics
How it works Cholinergic Muscarinic Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CEVIMELINE HCL 30 MG CAPSULE Ingredient Cevimeline Hcl
📗 Our plain-language guide HelloPharmacist
  • It treats dry mouth symptoms in people with Sjögren’s Syndrome. It comes as a capsule you take by mouth.
  • You take the capsule three times a day. Food slows how fast it is absorbed, so ask me about timing. Don’t take more than prescribed, since higher amounts haven’t been shown to help...
  • Sweating is the most common, and nausea, a runny nose and diarrhea can happen too. You may also notice extra saliva. Let your doctor know if they bother you.
  • Call if you have chest pain, heart rhythm changes, breathing trouble or vision changes. Be careful driving at night, since vision and depth perception can be affected.
📖 Read our full Cevimeline guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.729 $72.89 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.8432 $84.32 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $1.24 $124.32 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.729 $0.657
▲ Up 7% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69452-0316-20 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2024-01-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cevimeline Hydrochloride 30 mg 00054-0334-25 Hikma 100 capsules $0.729 AB Availability likely —
cevimeline hydrochloride 30 mg 00713-0937-01 Cosette 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 16571-0657-10 Rising 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 33342-0216-11 Macleods 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 59651-0422-01 Aurobindo 100 capsules $0.729 — Availability likely —
Cevimeline 30 mg 63304-0479-01 Sun 100 capsules $0.729 AB Availability likely —
Cevimeline 30 mgthis 69452-0316-20 Bionpharma 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 72578-0208-01 Viona 100 capsules $0.729 AB Availability likely —
Evoxac 30 mg 00713-0883-01 Cosette 100 capsules $8.591 AB Availability likely +1079%
cevimeline hydrochloride 30 mg 40032-0999-01 Novel 100 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 63629-9863-01 Bryant 30 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 70771-1982-01 Zydus 100 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 71335-2264-01 Bryant 30 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 71335-2326-01 Bryant 30 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 72162-2563-01 Bryant 100 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 72789-0457-01 PD-Rx 100 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 72888-0118-00 Advagen 1000 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 87063-0180-01 ASCLEMED 100 capsules — AB FDA listed —
cevimeline hydrochloride 30 mg 43386-0999-01 Lupin 100 capsules — AB FDA listed —
cevimeline hydrochloride 30 mg 71335-3168-01 Bryant 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBionpharma Inc
Application holderBIONPHARMA INC
FDA applicationANDA218290 (ANDA)
Labeler code69452
First marketedJan 2024
Product typeHuman Prescription Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

INDICATIONS AND USAGE Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.

⏱️ Dosage and Administration 49 words ▾

DOSAGE AND ADMINISTRATION The recommended dose of cevimeline hydrochloride capsules is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg tid.

⛔ Contraindications 27 words ▾

CONTRAINDICATIONS Cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

⚠️ Warnings 149 words ▾

WARNINGS Cardiovascular Disease Cevimeline can potentially alter cardiac conduction and/or heart rate. Patients with significant cardiovascular disease may potentially be unable to compensate for transient changes in hemodynamics or rhythm induced by cevimeline. Cevimeline should be used with caution and under close medical supervision in patients with a history of cardiovascular disease evidenced by angina pectoris or myocardial infarction.

Pulmonary Disease Cevimeline can potentially increase airway resistance, bronchial smooth muscle tone, and bronchial secretions. Cevimeline should be administered with caution and with close medical supervision to patients with controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease. Ocular Ophthalmic formulations of muscarinic agonists have been reported to cause visual blurring which may result in decreased visual acuity, especially at night and in patients with central lens changes, and to cause impairment of depth perception.

Caution should be advised while driving at night or performing hazardous activities in reduced lighting.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Cevimeline was administered to 1,777 patients during clinical trials worldwide, including Sjögren’s patients and patients with other conditions. In placebo-controlled Sjögren’s studies in the U.S., 320 patients received cevimeline doses ranging from 15 mg tid to 60 mg tid, of whom 93% were women and 7% were men. Demographic distribution was 90% Caucasian, 5% Hispanic, 3% Black and 2% of other origin.

In these studies, 14.6% of patients discontinued treatment with cevimeline due to adverse events. The following adverse events associated with muscarinic agonism were observed in the clinical trials of cevimeline in Sjögren’s syndrome patients: Adverse Event Cevimeline 30 mg (tid) n n is the total number of patients exposed to the dose at any time during the study. = 533 Placebo (tid) n = 164 Excessive Sweating 18.7% 2.4% Nausea 13.8% 7.9% Rhinitis 11.2% 5.4% Diarrhea 10.3% 10.3% Excessive Salivation 2.2% 0.6% Urinary Frequency 0.9% 1.8% Asthenia 0.5% 0.0% Flushing 0.3% 0.6% Polyuria 0.1% 0.6% In addition, the following adverse events (≥ 3% incidence) were reported in the Sjögren’s clinical trials: Adverse Event Cevimeline 30 mg (tid) n n is the total number of patients exposed to the dose at any time during the study. = 533 Placebo (tid) n = 164 Headache 14.4% 20.1% Sinusitis 12.3% 10.9% Upper Respiratory Tract Infection 11.4% 9.1% Dyspepsia 7.8% 8.5% Abdominal Pain 7.6% 6.7% Urinary Tract Infection 6.1% 3.0% Coughing 6.1% 3.0% Pharyngitis 5.2% 5.4% Vomiting 4.6% 2.4% Injury 4.5% 2.4% Back Pain 4.5% 4.2% Rash 4.3% 6.0% Conjunctivitis 4.3% 3.6% Dizziness 4.1% 7.3% Bronchitis 4.1% 1.2% Arthralgia 3.7% 1.8% Surgical Intervention 3.3% 3.0% Fatigue 3.3% 1.2% Pain 3.3% 3.0% Skeletal Pain 2.8% 1.8% Insomnia 2.4% 1.2% Hot Flushes 2.4% 0.0% Rigors 1.3% 1.2% Anxiety 1.3% 1.2% The following events were reported in Sjögren's patients at incidences of < 3% and ≥ 1%: constipation, tremor, abnormal vision, hypertonia, peripheral edema, chest pain, myalgia, fever, anorexia, eye pain, earache, dry mouth, vertigo, salivary gland pain, pruritus, influenza-like symptoms, eye infection, post-operative pain, vaginitis, skin disorder, depression, hiccup, hyporeflexia, infection, fungal infection, sialoadenitis, otitis media, erythematous rash, pneumonia, edema, salivary gland enlargement, allergy, gastroesophageal reflux, eye abnormality, migraine, tooth disorder, epistaxis, flatulence, toothache, ulcerative stomatitis, anemia, hypoesthesia, cystitis, leg cramps, abscess, eructation, moniliasis, palpitation, increased amylase, xerophthalmia, allergic reaction.

The following events were reported rarely in treated Sjögren's patients (< 1%): Causal relation is unknown: Body as a Whole Disorders : aggravated allergy, precordial chest pain, abnormal crying, hematoma, leg pain, edema, periorbital edema, activated pain trauma, pallor, changed sensation temperature, weight decrease, weight increase, choking, mouth edema, syncope, malaise, face edema, substernal chest pain Cardiovascular Disorders : abnormal ECG, heart disorder, heart murmur, aggravated hypertension, hypotension, arrhythmia, extrasystoles, t wave inversion, tachycardia, supraventricular tachycardia, angina pectoris, myocardial infarction, pericarditis, pulmonary embolism, peripheral ischemia, superficial phlebitis, purpura, deep thrombophlebitis, vascular disorder, vasculitis, hypertension Digestive Disorders : appendicitis, increased appetite, ulcerative colitis, diverticulitis, duodenitis, dysphagia, enterocolitis, gastric ulcer, gastritis, gastroenteritis, gastrointestinal hemorrhage, gingivitis, glossitis, rectum hemorrhage, hemorrhoids, ileus, irritable bowel syndrome, melena, mucositis, esophageal stricture, esophagitis, oral hemorrhage, peptic ulcer, periodontal destruction, rectal disorder, stomatitis, tenesmus, tongue discoloration, tongue disorder, geographic tongue, tongue ulceration, dental caries Endocrine Disorders : increased glucocorticoids, goiter, hypothyroid… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 84 words ▾

MANAGEMENT OF OVERDOSE Management of the signs and symptoms of acute overdosage should be handled in a manner consistent with that indicated for other muscarinic agonists: general supportive measures should be instituted. If medically indicated, atropine, an anti-cholinergic agent, may be of value as an antidote for emergency use in patients who have had an overdose of cevimeline. If medically indicated, epinephrine may also be of value in the presence of severe cardiovascular depression or bronchoconstriction.

It is not known if cevimeline is dialyzable.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics Cevimeline is a cholinergic agonist which binds to muscarinic receptors. Muscarinic agonists in sufficient dosage can increase secretion of exocrine glands, such as salivary and sweat glands and increase tone of the smooth muscle in the gastrointestinal and urinary tracts. Pharmacokinetics Absorption: After administration of a single 30 mg capsule, cevimeline was rapidly absorbed with a mean time to peak concentration of 1.5 hours to 2 hours.

No accumulation of active drug or its metabolites was observed following multiple dose administration. When administered with food, there is a decrease in the rate of absorption, with a fasting T max of 1.53 hours and a T max of 2.86 hours after a meal; the peak concentration is reduced by 17.3%. Single oral doses across the clinical dose range are dose proportional.

Distribution: Cevimeline has a volume of distribution of approximately 6L/kg and is < 20% bound to human plasma proteins. This suggests that cevimeline is extensively bound to tissues; however, the specific binding sites are unknown. Metabolism: Isozymes CYP2D6 and CYP3A3/4 are responsible for the metabolism of cevimeline.

After 24 hours, 86.7% of the dose was recovered (16% unchanged, 44.5% as cis and trans-sulfoxide, 22.3% of the dose as glucuronic acid conjugate and 4% of the dose as N-oxide of cevimeline). Approximately 8% of the trans-sulfoxide metabolite is then converted into the corresponding glucuronic acid conjugate and eliminated. Cevimeline did not inhibit cytochrome P450 isozymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4.

Excretion: The mean half-life of cevimeline is 5+ /-1 hours. After 24 hours, 84% of a 30 mg dose of cevimeline was excreted in urine. After seven days, 97% of the dose was recovered in the urine and 0.5% was recovered in the feces.

Special Populations: The effects of renal impairment, hepatic impairment, or ethnicity on the pharmacokinetics of cevimeline have not been investigated. Clinical Studies Cevimeline has been shown to improve the symptoms of dry mouth in patients with Sjögren’s Syndrome. A 6-week, randomized, double blind, placebo-controlled study was conducted in 75 patients (10 men, 65 women) with a mean age of 53.6 years (range 33 to 75).

The racial distribution was Caucasian 92%, Black 1% and other 7%. The effects of cevimeline at 30 mg tid (90 mg/day) and 60 mg tid (180 mg/day) were compared to those of placebo. Patients were evaluated by a measure called global improvement, which is defined as a response of "better" to the question, "Please rate the overall condition of your dry mouth now compared with how you felt before starting treatment in this study." Patients also had the option of selecting "worse" or "no change" as answers.

Seventy-six percent of the patients in the 30 mg tid group reported a global improvement in their dry mouth symptoms compared to 35% of the patients in the placebo group. This difference was statistically significant at p = 0.0043. There was no evidence that patients in the 60 mg tid group had better global evaluation scores than the patients in the 30 mg tid group.

A 12-week, randomized, double-blind, placebo-controlled study was conducted in 197 patients (10 men, 187 women) with a mean age of 54.5 years (range 23 to 74). The racial distribution was Caucasian 91.4%, Black 3% and other 5.6%. The effects of cevimeline at 15 mg tid (45 mg/day) and 30 mg tid (90 mg/day) were compared to those of placebo.

Statistically significant global improvement in the symptoms of dry mouth (p = 0.0004) was seen for the 30 mg tid group compared to placebo, but not for the 15 mg group compared to placebo. Salivary flow showed statistically significant increases at both doses of cevimeline during the study compared to placebo. A second 12-week, randomized, double-blind, placebo-controlled study was conducted in 212 patients (11 men, 201 women) with a mean age of 55.3 years (range 24 to 75).

The racial distribution was Caucasian 88.7%, B… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 101 words ▾

HOW SUPPLIED Cevimeline hydrochloride capsules are available as white, hard gelatin capsules with white opaque cap and white opaque body filled with white to off-white powder blend. The capsule is printed with CH in black ink on the body. It is supplied in child-resistant bottles of: 100 capsules (NDC 69452-316-20) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Dispense in tight containers. Keep this and all drugs out of the reach of children. Distributed by: Bionpharma Inc.

Princeton, NJ 08540 MADE IN INDIA Revised: 9/2023 FDA-04 948026810

📋 Description 140 words ▾

DESCRIPTION Cevimeline is cis-2’-methylspiro {1-azabicyclo [2.2.2] octane-3, 5’ -[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its molecular formula is C 10 H 17 NOS•HCl•½ H 2 O, and its structural formula is: Cevimeline hydrochloride, USP has a molecular weight of 244.79. It is a white to off white crystalline powder with a melting point range of 201°C and 203°C.

It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Each capsule for oral administration contains 30 mg of cevimeline hydrochloride, USP.

Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate. The capsule shell is composed of gelatin, and titanium dioxide. The capsules are printed with black ink composed of black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. structural formula

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Cevimeline toxicity is characterized by an exaggeration of its parasympathomimetic effects. These may include: headache, visual disturbance, lacrimation, sweating, respiratory distress, gastrointestinal spasm, nausea, vomiting, diarrhea, atrioventricular block, tachycardia, bradycardia, hypotension, hypertension, shock, mental confusion, cardiac arrhythmia, and tremors. Cevimeline should be administered with caution to patients with a history of nephrolithiasis or cholelithiasis.

Contractions of the gallbladder or biliary smooth muscle could precipitate complications such as cholecystitis, cholangitis and biliary obstruction. An increase in the ureteral smooth muscle tone could theoretically precipitate renal colic or ureteral reflux in patients with nephrolithiasis. Information for Patients Patients should be informed that cevimeline may cause visual disturbances, especially at night, that could impair their ability to drive safely.

If a patient sweats excessively while taking cevimeline, dehydration may develop. The patient should drink extra water and consult a health care provider. Drug Interactions Cevimeline should be administered with caution to patients taking beta adrenergic antagonists, because of the possibility of conduction disturbances.

Drugs with parasympathomimetic effects administered concurrently with cevimeline can be expected to have additive effects. Cevimeline might interfere with desirable antimuscarinic effects of drugs used concomitantly. Drugs which inhibit CYP2D6 and CYP3A3/4 also inhibit the metabolism of cevimeline.

Cevimeline should be used with caution in individuals known or suspected to be deficient in CYP2D6 activity, based on previous experience, as they may be at a higher risk of adverse events. In an in vitro study, cytochrome P450 isozymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4 were not inhibited by exposure to cevimeline. Carcinogenesis, Mutagenesis and Impairment of Fertility Lifetime carcinogenicity studies were conducted in CD-1 mice and F-344 rats.

A statistically significant increase in the incidence of adenocarcinomas of the uterus was observed in female rats that received cevimeline at a dosage of 100 mg/kg/day (approximately 8 times the maximum human exposure based on comparison of AUC data). No other significant differences in tumor incidence were observed in either mice or rats. Cevimeline exhibited no evidence of mutagenicity or clastogenicity in a battery of assays that included an Ames test, an in vitro chromosomal aberration study in mammalian cells, a mouse lymphoma study in L5178Y cells, or a micronucleus assay conducted in vivo in ICR mice.

Cevimeline did not adversely affect the reproductive performance or fertility of male Sprague-Dawley rats when administered for 63 days prior to mating and throughout the period of mating at dosages up to 45 mg/kg/day (approximately 5 times the maximum recommended dose for a 60 kg human following normalization of the data on the basis of body surface area estimates). Females that were treated with cevimeline at dosages up to 45 mg/kg/day from 14 days prior to mating through day seven of gestation exhibited a statistically significantly smaller number of implantations than did control animals.

Pregnancy Cevimeline was associated with a reduction in the mean number of implantations when given to pregnant Sprague-Dawley rats from 14 days prior to mating through day seven of gestation at a dosage of 45 mg/kg/day (approximately 5 times the maximum recommended dose for a 60 kg human when compared on the basis of body surface area estimates). This effect may have been secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women.

Cevimeline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether this drug is secreted in human milk. Because many drugs are excreted in human milk, and because of the p… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 29 words ▾

PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label NDC 69452-316-20 Cevimeline Hydrochloride Capsuels 30 mg Rx only 100 Capsules PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.5K
Units reimbursed last 4 qtrs
377.5K
Gross reimbursed last 4 qtrs
$318.3K
Avg / prescription
$89.76
Avg / unit
$0.8432
Latest quarter Q1 2026
1.1KRx
Medicaid pays / ea
$0.8432
gross reimbursed
vs
NADAC / ea
$0.7289
acquisition cost
=
Spread
+$0.1143
+16% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
52% FFS 48% MCO
Fee-for-service · 1,846 Rx Managed care · 1,700 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 7,491 units · 95.9 per 100k residents WA Idaho: 8,633 units · 440 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 21,062 units · 367 per 100k residents MN Wisconsin: 16,574 units · 280 per 100k residents WI Michigan: 2,461 units · 24.5 per 100k residents MI New York: 75,342 units · 385 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 11,675 units · 93.0 per 100k residents IL Indiana: 8,076 units · 118 per 100k residents IN Ohio: 29,515 units · 250 per 100k residents OH Pennsylvania: 31,246 units · 241 per 100k residents PA New Jersey: 23,520 units · 253 per 100k residents NJ Massachusetts: 5,700 units · 81.4 per 100k residents MA California: 29,359 units · 75.3 per 100k residents CA Utah: no data reported UT Colorado: 25,176 units · 428 per 100k residents CO Nebraska: no data reported NE Missouri: 15,295 units · 247 per 100k residents MO Kentucky: 12,676 units · 280 per 100k residents KY West Virginia: 13,647 units · 771 per 100k residents WV Virginia: no data reported VA Maryland: 1,380 units · 22.3 per 100k residents MD Connecticut: 14,569 units · 403 per 100k residents CT Rhode Island: no data reported RI Arizona: 2,190 units · 29.5 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 3,600 units · 50.5 per 100k residents TN North Carolina: 2,412 units · 22.3 per 100k residents NC South Carolina: no data reported SC Delaware: 2,594 units · 252 per 100k residents DE Oklahoma: 3,159 units · 77.9 per 100k residents OK Louisiana: 7,305 units · 160 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,740 units · 5.7 per 100k residents TX Florida: 1,095 units · 4.8 per 100k residents FL
Units reimbursed · per 100k residents
4.8771
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 771 /100k
2 Idaho 440 /100k
3 Colorado 428 /100k
4 Connecticut 403 /100k
5 New York 385 /100k
6 Minnesota 367 /100k
7 Wisconsin 280 /100k
8 Kentucky 280 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.