NDC 10544-086
Nitrofurantoin Monohydrate/ Macrocrystalline 25 mg / 75 mg capsule
On the label: Blenheim Pharmacal, Inc.. It's repackaged: Blenheim Pharmacal, Inc. rebottles it from Alvogen Inc.'s NDC 47781-303.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Norwich Pharmaceuticals, Inc. | Norwich, NY, United States | Makes it, tests it and packages it | No problems foundMay 1, 2026 · 8 inspections |
Repackaging site
- Blenheim Pharmacal, Inc., North Blenheim, New York, United States · repackages it
Recalls
- Jul 24, 2019 · Class II · Alvogen, Inc
Failed dissolution specifications
Lots: Lot # 471976, Exp 03/2020 - Apr 21, 2015 · Class II · Alvogen, Inc
Failed Dissolution Specification; 6 month time point
Lots: Lot 457529, exp. 08/2016
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nitrofurantoin: every company that makes it
- Form
- capsule
- Strength
- 25 mg / 75 mg
- Approval
- NDA NDA020064
- On the market since
- Sep 6, 2012
- Package NDCs
10544-086-14- Official label
- DailyMed (National Library of Medicine), updated Mar 16, 2015
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