NDC 68084-280
Ethambutol Hydrochloride 400 mg tablet
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-281.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
| Lupin Limited | Nagpur, India | Makes it and packages it | Problems found, fixed voluntarilyJul 11, 2023 · 4 inspections |
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
Recalls
- Feb 22, 2013 · Class III · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Lots: Lot #: 3122856, Exp 05/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ethambutol: every company that makes it
- Form
- tablet, oral
- Strength
- 400 mg
- Approval
- ANDA ANDA078939
- On the market since
- Dec 16, 2009
- Package NDCs
68084-280-0168084-280-11- Official label
- DailyMed (National Library of Medicine), updated Sep 18, 2025
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