Medicine
Clozapine 100 mg tablet
Clozapine 100 mg tablet is a generic prescription medicine for oral use, made by 9 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
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 10 blister pack and 11 more
- Manufacturers
- Aurobindo PharmaIndiaAccord HealthcareIndiaMylan PharmaceuticalsNorthStar RxAmerican Health PackagingCardinal HealthMajor PharmaceuticalsMylan InstitutionalSafecor Health
- 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
- 8 July 1999
- Identifiers
- RxCUI 197535, 197536, 309374 +1DailyMed set ID 7c748f8a-73ce-4bd3-aa30-9c66657f06ec, 9db7aefb-f607-4158-a310-181e631bc648, 25c0c6d5-f7b0-48e4-e054-00144ff8d46c +6NDC 55154-3568, 0904-7087, 16729-142 +6Application ANDA206433, ANDA202873, 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 | 16729-142-01 | Accord HealthcareIndia | 10 April 2017 |
| 500 tablet in 1 bottle | 16729-142-16 | Accord HealthcareIndia | 17 May 2017 |
| 100 tablet in 1 bottle | 65862-846-01 | Aurobindo PharmaIndia | 29 November 2016 |
| 500 tablet in 1 bottle | 65862-846-05 | Aurobindo PharmaIndia | 29 November 2016 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 65862-846-78 | Aurobindo PharmaIndia | 29 November 2016 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 51079-922-20 | Mylan Institutional | 15 November 1999 |
| 100 tablet in 1 bottle, plastic | 0378-0860-01 | Mylan Pharmaceuticals | 8 July 1999 |
| 500 tablet in 1 bottle, plastic | 0378-0860-05 | Mylan Pharmaceuticals | 5 February 2001 |
| 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 60687-415-01 | American Health Packaging | 2 January 2019 |
| 10 blister pack in 1 bag / 1 tablet in 1 blister pack | 55154-3568-0 | Cardinal Health | 29 November 2016 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-7087-61 | Major Pharmaceuticals | 29 November 2016 |
| 100 tablet in 1 bottle | 72603-913-01 | NorthStar Rx | 1 August 2026 |
| 500 tablet in 1 bottle | 72603-913-02 | NorthStar Rx | 1 August 2026 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 48433-024-20 | Safecor Health | 23 February 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
Alternatives
Other makers and brands of Clozapine 100 mg tablet.
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 100 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.