NDC 72189-162
Amlodipine Besylate 2.5 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Ascend Laboratories, LLC's NDC 67877-197.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it | No problems foundAug 30, 2019 · 6 inspections |
| Alkem Laboratories Limited | Baddi Solan, India | Makes it | Problems found, fixed voluntarilyMar 27, 2024 · 9 inspections |
| VKT Pharma Private Limited | Srikakulam, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyFeb 7, 2025 · 2 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- May 5, 2017 · Class III · Ascend Laboratories LLC
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Lots: Lot #: 6142626, Exp 09/19
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
- 2.5 mg
- Approval
- ANDA ANDA078925
- On the market since
- Jan 12, 2021
- Package NDCs
72189-162-90- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2025
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