NDC 68180-459
Amlodipine Besylate and Benazepril Hydrochloride 5 mg / 20 mg capsule
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
| Lupin Limited | Pithampur, India | Makes it and packages it | Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action |
Recalls
- Jul 2, 2025 · Class II · Lupin Pharmaceuticals Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Lots: Lot GB01616, expiration 2/28/2027
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 and Benazeprilat: every company that makes it
- Form
- capsule, oral
- Strength
- 5 mg / 20 mg
- Approval
- ANDA ANDA078466
- On the market since
- Aug 1, 2018
- Package NDCs
68180-459-0168180-459-0268180-459-03- Official label
- DailyMed (National Library of Medicine), updated Oct 3, 2025
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