Quick answers
- What is Nitrofurantoin Mono?
- Nitrofurantoin Mono is a brand name of Nitrofurantoin (monohydrate/macrocrystals), a prescription medicine. The FDA NDC Directory lists 1 Nitrofurantoin Mono product in 1 strength and form.
- Who makes Nitrofurantoin Mono?
- Almatica holds the FDA application for Nitrofurantoin Mono (NDA020064, approved December 24, 1991).
- Is there a generic or store brand of Nitrofurantoin Mono?
- Yes. The FDA NDC Directory lists 62 other products with the same active ingredients, strength and form as a Nitrofurantoin Mono product, 56 of them generic. Ask your pharmacist whether one is right for you.
- Has Nitrofurantoin Mono been recalled?
- No recall linked to Nitrofurantoin Mono products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Nitrofurantoin Mono is
Each Nitrofurantoin Mono product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Nitrofurantoin (monohydrate/macrocrystals) · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| nitrofurantoin 25 mg · nitrofurantoin monohydrate 75 mg capsule (oral) | Nitrofurantoin Mono | 62 products, 29 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Nitrofurantoin (monohydrate/macrocrystals) →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020064 | Almatica | December 24, 1991 | 1 |
Companies that list Nitrofurantoin Mono
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Nitrofurantoin Mono products.
- PharmPak, Inc.1 product
Recalls
No recall linked to Nitrofurantoin Mono products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.