clozapine
Pharmaranks rates Clozapine 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Clozapine is an atypical antipsychotic used to treat Bipolar Disorder, Psychotic Disorders, Schizophrenia.
Atypical Antipsychotic · by Par Pharm
Generic of Clozaril
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Clozapine
- Drug class
- Atypical Antipsychotic
- Form
- Tablet, Tablet, orally disintegrating
- Strength
- Clozapine 100MG · Clozapine 25MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- bipolar disorder, psychotic disorders, schizophrenia
- Manufacturer
- Par Pharm
- Half-life
- about 12 hours at steady state (the label gives a mean elimination half-life of 12 hours, range 4 to 66 hours, after 100 mg twice daily); after a single 75 mg dose the mean is 8 hours (range 4 to 12 hours) (how long it stays in your system)
- What the pharmacy pays
- ~$30.62 for 30 — not your price
- FDA application
- ANDA075162
- Availability
- Discontinued (per FDA)
Storing Clozapine, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store clozapine tablets at room temperature between 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].”
How long does Clozapine stay in your body?
The elimination half-life of clozapine is about 12 hours at steady state (the label gives a mean elimination half-life of 12 hours, range 4 to 66 hours, after 100 mg twice daily); after a single 75 mg dose the mean is 8 hours (range 4 to 12 hours) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label reports two different elimination half-lives and says so explicitly: 8 hours mean after a single dose versus 12 hours mean at steady state, noting the half-life "increased significantly after multiple dosing," which it attributes to possible concentration-dependent pharmacokinetics. For someone taking clozapine regularly, the steady-state figure (mean 12 hours) is the applicable one, and the range around it is wide (4 to 66 hours) — individual variation is large. Metabolites: clozapine is almost completely metabolized before excretion, via CYP1A2, CYP2D6 and CYP3A4. Its main metabolite, desmethylclozapine (norclozapine), is described by the label as having "only limited activity," and the hydroxylated and N-oxide derivatives as inactive; the label does not state a half-life for any metabolite, so no metabolite half-life is reported here. Special populations: the label states that no specific pharmacokinetic studies were done in renal or hepatic impairment, but that "higher clozapine plasma concentrations are likely in patients with significant renal or hepatic impairment when given usual doses" — it gives no altered half-life number for them. It also flags CYP2D6 poor metabolizers (3-10% of people) as likely to reach higher-than-expected concentrations, and notes case reports where pneumonia or other inflammatory conditions raised clozapine levels. This is elimination pharmacokinetics only — not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CLOZAPINE tablet, orally disintegrating — FDA Prescribing Information, §12.3 Pharmacokinetics (DailyMed).
Drug class
How this class works, per Atypical Antipsychotic Agents - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Clozapine ranks — best-rated atypical antipsychotic for:
Dosage forms
Tablet and Tablet, orally disintegrating
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Clozapine treat?
- Clozapine (Clozapine) may be used to treat bipolar disorder, psychotic disorders, schizophrenia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Clozapine work?
- Clozapine is a atypical antipsychotic. Atypical antipsychotics block dopamine D2 receptors and serotonin 5-HT2A receptors in the brain, rebalancing these signaling chemicals to reduce hallucinations, delusions, and mood symptoms in conditions like schizophrenia and bipolar disorder.
- How is Clozapine rated?
- pharmaranks gives Clozapine a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Clozapine cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $30.62 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Geodon — about $9.48 on the same basis.
- Is there a coupon or discount for Clozapine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Clozapine. To pay less, Clozapine is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Clozapine?
- Clozapine is marketed by Par Pharm. You can see Par Pharm's full profile, rating, and other products on pharmaranks.
- Is Clozapine a brand-name or generic drug?
- Clozapine is a generic medication; its active ingredient is Clozapine. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Clozapine available over the counter?
- No. Clozapine is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Clozapine come in?
- Clozapine is currently marketed as tablet and tablet, orally disintegrating, per the FDA's National Drug Code Directory.
- What class of drug is Clozapine?
- Clozapine is classified as atypical antipsychotic, per the FDA's Established Pharmacologic Class.
- Is Clozapine FDA-registered?
- Clozapine is on record with the U.S. FDA under application number ANDA075162. You can verify this on its official FDA label.
- Has Clozapine been recalled by the FDA?
- Clozapine has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Clozapine safe?
- There's no single safe-or-not verdict. pharmaranks gives Clozapine a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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clozapine
70/100