NDC 0904-7088
Clozapine 200 mg tablet
On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Aurobindo Pharma Limited's NDC 65862-847.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Jun 12, 2020 · Class II · Aurobindo Pharma USA Inc.
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Lots: Lot #: CZSC20003-A, Exp 1/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Clozapine: every company that makes it
- Form
- tablet, oral
- Strength
- 200 mg
- Approval
- ANDA ANDA206433
- On the market since
- Nov 29, 2016
- Package NDCs
0904-7088-61- Official label
- DailyMed (National Library of Medicine), updated Jan 5, 2026
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