NDC 63187-914
Amlodipine Besylate 10 mg tablet
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Cipla USA., Inc.'s NDC 69097-128.
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 | Raigad, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyApr 4, 2024 · 7 inspections |
| Cipla Limited | Bengaluru, India | Makes the active ingredient | Problems found, fixed voluntarilyNov 13, 2024 · 7 inspections |
Repackaging site
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and 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, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA077073
- On the market since
- Sep 26, 2007
- Package NDCs
63187-914-3063187-914-6063187-914-90- Official label
- DailyMed (National Library of Medicine), updated Feb 1, 2020
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