Histamine-2 Receptor Antagonist
Where is Nizatidine made?
4 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 2 factories in India and the United States.
India 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Dr.Reddy's Laboratories Ltd.150 mg, 300 mg · NDC 55111-310, 55111-311 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Epic Pharma, LLC150 mg, 300 mg · NDC 42806-299, 42806-300 | Epic Pharma, LLCMakes it | Laurelton, NY, United States | Problems found, fixed voluntarilyJun 2026 |
| Actavis Pharma, Inc.150 mg, 300 mg · NDC 0591-3137, 0591-3138 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals15 mg per 1 mL · NDC 60846-301 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Nizatidine 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.
- Carilion Materials Management:
68151-0017 - Dispensing Solutions Inc.:
68258-3006 - H.J. Harkins Co., Inc.:
52959-824 - Medsource Pharmaceuticals:
45865-374 - Rebel Distributors Corp..:
21695-375,42254-093,21695-043 - Stat Rx USA:
16590-741
Recalls
- Apr 15, 2020 · Class II · Amneal Pharmaceuticals of New York, LLC
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.