Cipla Limited
Salcette, India · makes it, tests it, packages it and labels it
Problems found, fixed voluntarily Last FDA inspection Jun 21, 2024. 12 inspections on record, 2 with serious problems.
NDC 45865-810
Amlodipine Besylate 10 mg tablet
On the label: Medsource Pharmaceuticals.
It's a repackaged product: Medsource Pharmaceuticals rebottles it from Cipla USA., Inc.'s NDC 69097-128.
Where the pills inside were made
Cipla Limited
Indore, India · makes it, tests it, packages it and labels it
Serious problems, FDA action Last FDA inspection Feb 17, 2023. 6 inspections on record, 1 with serious problems.
Cipla Limited
Raigad, India · makes it, tests it, packages it and labels it
Problems found, fixed voluntarily Last FDA inspection Apr 4, 2024. 7 inspections on record.
Cipla Limited
Bengaluru, India · makes the active ingredient
Problems found, fixed voluntarily Last FDA inspection Nov 13, 2024. 7 inspections on record.
Repackaging site
- Medsource Pharmaceuticals, Rancho Santa Margarita, CA, United States · repackages it
Recalls
- Oct 3, 2018 · Class III · Terminated
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
Product details
- Generic drug
- Amlodipine: see every company that makes it
- Form
- tablet
- Strength
- 10 mg
- Approval
- ANDA ANDA077073
- On the market since
- Sep 26, 2007
- Package NDCs
45865-810-49- Official label
- DailyMed (National Library of Medicine), updated Dec 24, 2018
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