NDC 60687-415
Clozapine 100 mg tablet
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Aurobindo Pharma Limited's NDC 65862-846.
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 |
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
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
- 100 mg
- Approval
- ANDA ANDA206433
- On the market since
- Jan 2, 2019
- Package NDCs
60687-415-0160687-415-11- Official label
- DailyMed (National Library of Medicine), updated Sep 3, 2025
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