Medicine
Clozapine 50 mg tablet
Clozapine 50 mg tablet is a generic prescription medicine for oral use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store clozapine tablets, USP at room temperature between 20° to 25°C (68° to…
Key facts
- Active ingredient (INN)
- Clozapine
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 10 blister pack and 4 more
- Manufacturers
- Aurobindo PharmaIndiaAmerican Health PackagingMajor PharmaceuticalsMylan PharmaceuticalsNorthStar Rx
- Origin register
- US FDA, United States
- Storage
- Store clozapine tablets, USP at room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05AH02 Clozapine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 April 2010
- Identifiers
- RxCUI 197535, 197536, 309374 +1DailyMed set ID 9db7aefb-f607-4158-a310-181e631bc648, 5021d643-32d2-4167-b5d8-90870e68a787, 61fe53d5-ed5c-4e45-9189-709d08d386cb +2NDC 0904-7406, 65862-845, 72603-912 +2Application ANDA206433, ANDA075417
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 65862-845-01 | Aurobindo PharmaIndia | 29 November 2016 |
| 500 tablet in 1 bottle | 65862-845-05 | Aurobindo PharmaIndia | 29 November 2016 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 65862-845-78 | Aurobindo PharmaIndia | 29 November 2016 |
| 100 tablet in 1 bottle, plastic | 0378-0972-01 | Mylan Pharmaceuticals | 20 April 2010 |
| 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 60687-548-01 | American Health Packaging | 7 July 2020 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-7406-61 | Major Pharmaceuticals | 29 November 2016 |
| 100 tablet in 1 bottle | 72603-912-01 | NorthStar Rx | 1 August 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 26 September 1989 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Clozapine
Clinical summary
Clozapine is an atypical antipsychotic indicated for treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment, among other approved uses. MedsAcross supplies Clozapine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about ClozapineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Clozaril prescribing information (HLS Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Clozapine 50 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.