Nitrate Vasodilator
Where is Isosorbide Dinitrate made?
9 companies sell it under their own name and 11 repackagers rebottle it. Their labels name 4 factories in India, Jordan and Canada.
India 2Jordan 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BluePoint Laboratories.5 mg, 10 mg, 20 mg, 30 mg · NDC 68001-374, 68001-375, 68001-562 +1 | Hikma Pharmaceuticals LLCMakes it | Amman, Jordan | Problems found, fixed voluntarilySep 2019 |
| Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 | |
| Advagen Pharma Ltd.5 mg, 10 mg, 20 mg, 30 mg, 40 mg · NDC 72888-082, 72888-083, 72888-084 +2 | Rubicon Research LimitedMakes it, tests it and labels it | Thane, India | No problems foundMar 2024 |
| Cadila Healthcare Limited5 mg, 10 mg, 20 mg, 30 mg, 40 mg · NDC 70771-1502, 70771-1503, 70771-1504 +2 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Hikma Pharmaceuticals USA Inc.2.5 mg, 5 mg, 10 mg, 20 mg · NDC 0143-1771, 0143-1765, 0143-1772 +2 | West-ward Pharmaceutical CorpMakes it | Location not on file | Not inspected on record |
| Northstar Rx LLC.5 mg, 10 mg, 20 mg, 30 mg · NDC 16714-008, 16714-009, 16714-010 +1 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Oceanside Pharmaceuticals.5 mg, 40 mg · NDC 68682-192, 68682-193 | Bausch Health Companies Inc.Makes it and packages it | Steinbach, Canada | No problems foundMay 2023 |
| Zydus Pharmaceuticals (USA) Inc.5 mg, 10 mg, 20 mg, 30 mg, 40 mg · NDC 70710-1149, 70710-1150, 70710-1151 +2 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Par Health USA, LLC5 mg, 10 mg, 20 mg, 30 mg, 40 mg · NDC 49884-021, 49884-022, 49884-009 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.5 mg, 10 mg, 20 mg · NDC 0781-1556, 0781-1695, 0781-1635 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Isosorbide Dinitrate 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.
- American Health Packaging:
68084-082,68084-083 - AvPAK:
50268-448,50268-449,50268-447 - Bryant Ranch Prepack:
63629-9593 - Cardinal Health 107, LLC:
55154-7990,55154-7991 - Carilion Materials Management:
68151-2472,68151-2476,68151-1980,68151-2510+1 - Golden State Medical Supply, Inc.:
51407-148,51407-149,51407-147 - Major Pharmaceuticals:
0904-6619,0904-6620 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8463,0615-8464,0615-8465 - Proficient Rx LP:
82804-117,82804-108 - Remedyrepack Inc.:
70518-4405 - State of Florida DOH Central Pharmacy:
53808-0626
Recalls
- Nov 2, 2018 · Class II · Sandoz Inc
Cross Contamination with Other Products
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.