Home › NDC Lookup › Ingredients › Cevimeline Hydrochloride › 71335-3168-02
cevimeline hydrochloride 30 mg Capsule, 60-count — NDC 71335-3168-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

cevimeline hydrochloride 30 mg Capsule, 60-count — NDC 71335-3168-2 (Billing 71335-3168-02)

by Bryant Ranch Prepack · 60 CAPSULE in 1 BOTTLE

This is a package of 60 capsules of cevimeline hydrochloride 30 mg Capsule from Bryant Ranch Prepack, marketed since Jan 2023 and currently FDA-listed.

NDC 71335-3168-02
🏷️ FDA NDC (as labeled) 71335-3168-2 billing pads the package segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Product page 71335-3168-01 Also comes in: 30 capsules 71335-3168-1 90 capsules 71335-3168-3
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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) 71335-3168-2
Product NDC 71335-3168
11-digit billing NDC 71335316802
RxCUI 309140
UNII P81Q6V85NP
Application # NDA020989
SPL Set ID 7fa69ad5-7fa7-4078-9328-aacbb0d145a4
Established class (EPC) Cholinergic Receptor Agonist
Mechanism of action Cholinergic Muscarinic Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-03
Route ORAL
Dosage form CAPSULE
Substance CEVIMELINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 309140
Why two NDCs? The FDA registers this code as 71335-3168-2 — a 5-4-1 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 package segment → 71335-3168-02. 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

📖 What it is MedlinePlus · NLM

Cevimeline is used to treat the symptoms of dry mouth in patients with Sjogren's syndrome (a condition that affects the immune system and causes dryness of certain parts of the body such as the eyes and mouth). Cevimeline is in a class of medications called cholinergic agonists. It works by increasing the amount of saliva in the mouth.

Read the full MedlinePlus article ↗
📗 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 capsules 90 capsules
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
71335-3168-01 71335-3168-1 Main listing 30 CAPSULE in 1 BOTTLE 2026-08-04 — Active
71335-3168-02 You're viewing this 60 CAPSULE in 1 BOTTLE 2026-08-04 — Active
71335-3168-03 71335-3168-3 90 CAPSULE in 1 BOTTLE 2026-08-04 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 capsule in 1 bottle.
How does this package differ from NDC 71335-3168-01?
Both are cevimeline hydrochloride 30 mg Capsule — the drug itself is identical. This page's package is the 60-count one, while NDC 71335-3168-01 is the 30 capsules package.
What NDC number is used to bill for this package of cevimeline hydrochloride 30 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
cevimeline hydrochloride 30 mg 00713-0937-01 Cosette 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 59651-0422-01 Aurobindo 100 capsules $0.729 AB Availability likely —
Cevimeline 30 mg 69452-0316-20 Bionpharma 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 00054-0334-25 Hikma 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 16571-0657-10 Rising 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 —
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 72162-2563-01 Bryant 100 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 71335-2326-01 Bryant 30 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 70771-1982-01 Zydus 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 71335-2264-01 Bryant 30 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 mgthis 71335-3168-02 Bryant 60 capsules — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

What it looks like

Color white
ShapeCapsule
ImprintEVOXAC;30;mg
Size15 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerBryant Ranch Prepack
Application holderCOSETTE PHARMACEUTICALS INC
FDA applicationNDA020989 (NDA)
Labeler code71335
First marketedJan 2023
Product typeHuman Prescription Drug
Portfolio4,436 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 19 words ▾

INDICATIONS AND USAGE Cevimeline is 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 1777 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*=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% * n is the total number of patients exposed to the dose at any time during the study.

In addition, the following adverse events (≥3% incidence) were reported in the Sjögren’s clinical trials: Adverse Event Cevimeline 30 mg (tid) n*=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% * n is the total number of patients exposed to the dose at any time during the study.

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, hypothyroidism Hem… [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. Pharmacokine tics Absorption: After administration of a single 30 mg capsule, cevimeline was rapidly absorbed with a mean time to peak concentration of 1.5 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 (16.0% 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+ /-1hours. 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 33-75).

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 23-74). 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 24-75).

The racial distribution was Caucasian 88.7%, Black 1.9% and othe… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 97 words ▾

HOW SUPPLIED Cevimeline is available as white, hard gelatin capsules containing 30 mg of cevimeline hydrochloride. Cevimeline hydrochloride capsules have a white opaque cap and a white opaque body. The capsules are imprinted with “EVOXAC” on the cap and “30 mg” on the body with a black bar above “30 mg”.

It is supplied in child resistant bottles of: NDC 71335-3168-1: 30 CAPSULEs in a BOTTLE NDC 71335-3168-2: 60 CAPSULEs in a BOTTLE NDC 71335-3168-3: 90 CAPSULEs in a BOTTLE Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F) Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 95 words ▾

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

⚠️ 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… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 5 words ▾

Cevimeline Hydrochloride 30mg Capsules Label

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

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 capsules (71335-3168-01), 90 capsules (71335-3168-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71335-3167-01 · Bryant 71335-3169-01 · Bryant →
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.