Alkem Laboratories Limited
Amaliya Daman, India · makes it
No problems found Last FDA inspection Aug 30, 2019. 6 inspections on record.
NDC 51655-586
Amlodipine Besylate 10 mg tablet
On the label: Northwind Pharmaceuticals.
It's a repackaged product: Northwind Pharmaceuticals rebottles it from Ascend Laboratories, LLC's NDC 67877-199.
Where the pills inside were made
Alkem Laboratories Limited
Baddi Solan, India · makes it
Problems found, fixed voluntarily Last FDA inspection Mar 27, 2024. 9 inspections on record.
VKT Pharma Private Limited
Srikakulam, India · makes it, tests it and packages it
Problems found, fixed voluntarily Last FDA inspection Feb 7, 2025. 2 inspections on record.
Repackaging site
- Northwind Health Company, LLC, Indianapolis, IN, United States · repackages it
Recalls
- May 5, 2017 · Class III · Terminated
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
Product details
- Generic drug
- Amlodipine: see every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA078925
- On the market since
- Jan 3, 2023
- Package NDCs
51655-586-52- Official label
- DailyMed (National Library of Medicine), updated Jan 1, 2026
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