Thiazide Diuretic, beta-Adrenergic Blocker
Where is Bisoprolol and Hydrochlorothiazide made?
9 companies sell it under their own name and 9 repackagers rebottle it. Their labels name 4 factories in India and the United States.
India 3United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| ANI Pharmaceuticals, Inc.2.5 mg / 6.25 mg, 5 mg / 6.25 mg, 10 mg / 6.25 mg · NDC 70954-414, 70954-412, 70954-413 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Aurobindo Pharma Limited2.5 mg / 6.25 mg, 5 mg / 6.25 mg, 10 mg / 6.25 mg · NDC 59651-680, 59651-678, 59651-679 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cadila Healthcare Limited2.5 mg / 6.25 mg, 5 mg / 6.25 mg, 10 mg / 6.25 mg · NDC 70771-1762, 70771-1760, 70771-1761 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Glenmark Pharmaceuticals Inc., USA2.5 mg / 6.25 mg, 5 mg / 6.25 mg, 10 mg / 6.25 mg · NDC 68462-880, 68462-878, 68462-879 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Viona Pharmaceuticals Inc.2.5 mg / 6.25 mg, 5 mg / 6.25 mg, 10 mg / 6.25 mg · NDC 72578-115, 72578-113, 72578-114 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Edenbridge Pharmaceuticals LLC.2.5 mg / 6.25 mg, 5 mg / 6.25 mg, 10 mg / 6.25 mg · NDC 42799-922, 42799-920, 42799-921 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.2.5 mg / 6.25 mg, 5 mg / 6.25 mg, 10 mg / 6.25 mg · NDC 0378-0505, 0378-0501, 0378-0503 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.2.5 mg / 6.25 mg, 5 mg / 6.25 mg, 10 mg / 6.25 mg · NDC 0093-3243, 0093-3241, 0093-3242 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.2.5 mg / 6.25 mg, 5 mg / 6.25 mg, 10 mg / 6.25 mg · NDC 29300-189, 29300-187, 29300-188 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Bisoprolol and Hydrochlorothiazide in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-6030,50090-5905,50090-6478,50090-6413+2 - Aidarex Pharmaceuticals LLC:
33261-918 - Blenheim Pharmacal, Inc.:
10544-174,10544-173,10544-563 - Bryant Ranch Prepack:
71335-2616,71335-1931,71335-1161,71335-2589+2 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-705 - Marlex Pharmaceuticals, Inc.:
10135-742,10135-740,10135-741 - Physicians Total Care, Inc.:
54868-4578,54868-4577,54868-4576 - Rebel Distributors Corp..:
21695-809,21695-808 - RedPharm Drug. Inc.:
67296-1268,67296-0947
Recalls
- Jan 21, 2026 · Class II · Unichem Pharmaceuticals USA Inc.
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. - Oct 20, 2023 · Class III · Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.