NDC 68180-199
Telmisartan and Amlodipine 10 mg / 80 mg tablet
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
Recalls
- Apr 1, 2019 · Class III · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Lots: G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 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 and Telmisartan: every company that makes it
- Form
- tablet
- Strength
- 10 mg / 80 mg
- Approval
- ANDA ANDA201586
- On the market since
- Jan 8, 2014
- Package NDCs
68180-199-0668180-199-0968180-199-12- Official label
- DailyMed (National Library of Medicine), updated Dec 15, 2023
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