NDC 71335-2589
Bisoprolol Fumarate and Hydrochlorothiazide 5 mg / 6.25 mg tablet, film coated
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-879.
Where the pills inside were 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 |
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
Recalls
- Oct 20, 2023 · Class III · Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications
Lots: Lot# 17212352, Exp 11/31/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bisoprolol and Hydrochlorothiazide: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 5 mg / 6.25 mg
- Approval
- ANDA ANDA215995
- On the market since
- Jan 26, 2022
- Package NDCs
71335-2589-171335-2589-271335-2589-371335-2589-4- Official label
- DailyMed (National Library of Medicine), updated Jun 4, 2025
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