NDC 67877-499
Amlodipine and olmesartan Medoxomil 5 mg / 20 mg tablet
On the label: Ascend Laboratories, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Baddi Solan, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMar 27, 2024 · 9 inspections |
Recalls
- Oct 6, 2026 · Class II · Ascend Laboratories, LLC
Out of specification due to dissolution.
Lots: Lot # 25120696, Exp Date: December 31, 2026. - Jul 8, 2026 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Lots: Lot 25121311, expiry 3/31/2028 - May 5, 2026 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Lots: Lot: 24123460, Expires: October 31, 2027. - Jul 21, 2025 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications: low dissolution results
Lots: Lot 23121560, Exp 4/30/2026
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 Olmesartan: every company that makes it
- Form
- tablet, oral
- Strength
- 5 mg / 20 mg
- Approval
- ANDA ANDA209042
- On the market since
- Aug 14, 2017
- Package NDCs
67877-499-3067877-499-90- Official label
- DailyMed (National Library of Medicine), updated May 30, 2025
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