NDC 68462-841
Telmisartan and Hydrochlorothiazide 80 mg / 12.5 mg tablet
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Jun 29, 2022 · Class II · Glenmark Pharmaceuticals Inc., USA
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Lots: Lots 17210935 & 17210936., Exp Date 05/2023 Lot 17211206, Exp Date 06/2023 Lots 17211652, 17211655 & 17211658, Exp Date 08/2023 - Jun 29, 2022 · Class II · Glenmark Pharmaceuticals Inc., USA
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Lots: Lots 17210929 & 17210930, Exp Date 05/2023; Lot 17211203, Exp Date 06/2023 & Lots 17211643, 17211646 & 17211649, Exp Date 08/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydrochlorothiazide and Telmisartan: every company that makes it
- Form
- tablet, oral
- Strength
- 80 mg / 12.5 mg
- Approval
- ANDA ANDA202544
- On the market since
- Mar 4, 2019
- Package NDCs
68462-841-13- Official label
- DailyMed (National Library of Medicine), updated Jan 7, 2026
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