Zydus Lifesciences Limited
Ahmedabad, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Aug 5, 2022. 10 inspections on record, 3 with serious problems.
NDC 48433-156
Amlodipine Besylate 5 mg tablet
On the label: Safecor Health, LLC.
It's a repackaged product: Safecor Health, LLC rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-122.
Where the pills inside were made
Zydus Lifesciences Limited
Solan, India · makes it and tests it
No problems found Last FDA inspection Mar 9, 2020. 6 inspections on record.
Recalls
- Oct 1, 2014 · Class III · Terminated
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Lots: Lot #: MP4344, Exp 04/2016
Product details
- Generic drug
- Amlodipine: see every company that makes it
- Form
- tablet, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA078226
- On the market since
- Jun 1, 2026
- Package NDCs
48433-156-0148433-156-20- Official label
- DailyMed (National Library of Medicine), updated Jun 12, 2026
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