NDC 76413-141
Amlodipine Besylate 5 mg tablet
On the label: Central Texas Community Health Centers. It's repackaged: Central Texas Community Health Centers rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-122.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
Repackaging site
- Central Texas Community Health Centers, Austin, Texas, United States · repackages it and relabels it
Recalls
- Oct 1, 2014 · Class III · Zydus Pharmaceuticals USA Inc
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Lots: Lot #: MP4344, Exp 04/2016
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
- Strength
- 5 mg
- Approval
- ANDA ANDA078226
- On the market since
- Sep 21, 2007
- Package NDCs
76413-141-30- Official label
- DailyMed (National Library of Medicine), updated May 26, 2016
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