NDC 67046-1157
Amlodipine Besylate 10 mg tablet
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-721.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Chhatrapati Sambhajinagar, India | Makes it and packages it | Problems found, fixed voluntarilyMar 15, 2024 · 5 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Jun 27, 2023 · Class III · Lupin Pharmaceuticals Inc.
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Lots: Lot #: A102887, Exp. 6/2023 - Feb 19, 2016 · Class III · Lupin Limited
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Lot #: G304799, Exp. 4/2016 - Feb 19, 2016 · Class III · Lupin Limited
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Amlodipine: every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA078043
- On the market since
- Sep 8, 2026
- Package NDCs
67046-1157-3- Official label
- DailyMed (National Library of Medicine), updated Sep 8, 2026
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