United States · FDA National Drug Code directory
Nitrofurantoin (monohydrate/macrocrystals)
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 65162-478_7a5a2365-bab1-46d8-a6e6-95c623dbea9a
- Product NDC
- 65162-478
- Form
- CAPSULE
- Composition / generic term
- Nitrofurantoin monohydrate/macrocrystals
- Labeler
- Amneal Pharmaceuticals LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20170525 / 20261130
Source-listed ingredients
- NITROFURANTOIN MONOHYDRATE — 75 mg/1
- NITROFURANTOIN — 25 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 100 CAPSULE in 1 BOTTLE (65162-478-10) · 65162-478-10
Source and coverage
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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
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