Quick answers
- What is Macrobid?
- Macrobid is a brand name of Nitrofurantoin (monohydrate/macrocrystals), a prescription medicine. The FDA NDC Directory lists 2 Macrobid products in 1 strength and form.
- Who makes Macrobid?
- Almatica holds the FDA application for Macrobid (NDA020064, approved December 24, 1991). 1 other company (repackagers or distributors) also list Macrobid products.
- Is there a generic or store brand of Macrobid?
- Yes. The FDA NDC Directory lists 61 other products with the same active ingredients, strength and form as a Macrobid product, 56 of them generic. Ask your pharmacist whether one is right for you.
- Has Macrobid been recalled?
- FDA enforcement reports list 1 recall of Macrobid products; the newest started July 24, 2019. A recall usually concerns specific lots, not every product.
What Macrobid is
Each Macrobid 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) | Macrobid | 61 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 | 2 |
Companies that list Macrobid
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Macrobid products.
- Almatica Pharma LLC1 product
- Remedyrepack Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 24, 2019 · Class II · Terminated · D-1723-2019
Failed dissolution specifications
Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01 — Alvogen, Inc
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.