NDC 68071-1348
Amlodipine Besylate 5 mg tablet
On the label: NuCare Pharmaceuticals.Inc.. It's repackaged: NuCare Pharmaceuticals.Inc. rebottles it from Cipla USA., Inc.'s NDC 69097-127.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla Limited | Salcette, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJun 21, 2024 · 12 inspections, 2 with FDA action |
| Cipla Limited | Indore, India | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 17, 2023 · 6 inspections, 1 with FDA action |
| Cipla Limited | Bengaluru, India | Makes the active ingredient | Problems found, fixed voluntarilyNov 13, 2024 · 7 inspections |
Repackaging site
- NuCare Pharmaceuticals,Inc., Orange, CA, United States · relabels it
Recalls
- Oct 3, 2018 · Class III · InvaGen Pharmaceuticals, Inc.
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Lots: Lot #: GG80218, Exp. 12/2019
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 ANDA077073
- On the market since
- Sep 26, 2007
- Package NDCs
68071-1348-9- Official label
- DailyMed (National Library of Medicine), updated Feb 10, 2021
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