Quick answers
- What is Nitrofurantoin (monohydrate/macrocrystals) used for?
- The FDA-approved label (Macrobid, Remedyrepack Inc., February 9, 2026) says: “Macrobid is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nitrofurantoin (monohydrate/macrocrystals) have a boxed warning?
- No. None of the 59 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nitrofurantoin (monohydrate/macrocrystals)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nitrofurantoin (monohydrate/macrocrystals) been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started July 24, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Nitrofurantoin (monohydrate/macrocrystals)?
- 30 companies list prescription products of Nitrofurantoin (monohydrate/macrocrystals) in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and NuCare Pharmaceuticals, Inc..
What Nitrofurantoin (monohydrate/macrocrystals) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Macrobid is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. …
— FDA label: Macrobid, Remedyrepack Inc., effective February 9, 2026. Read the full label on DailyMed →
The FDA has 59 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 59 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 63 in the FDA NDC Directory |
| Brand names | Macrobid, Nitrofurantoin Monohydrate Macrocrystalline, Nitrofurantoin Mono |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| nitrofurantoin 25 mg · nitrofurantoin monohydrate 75 mg capsule | Generic | $0.2719 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack8 products
- Remedyrepack Inc.6 products
- NuCare Pharmaceuticals, Inc.5 products
- PD-Rx Pharmaceuticals, Inc.4 products
- Proficient Rx LP4 products
- Northwind Health Company, LLC3 products
- A-S Medication Solutions3 products
- St. Mary's Medical Park Pharmacy3 products
- Coupler LLC2 products
- Redpharm Drug2 products
- QPharma, Inc.2 products
- Direct_Rx2 products
- Jubilant Cadista Pharmaceuticals Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Asclemed USA, Inc.2 products
- Almatica Pharma LLC1 product
- Lifestar Pharma LLC1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Amneal Pharmaceuticals LLC1 product
- Sandoz Inc1 product
- DirectRx1 product
- PharmPak, Inc.1 product
- Major Pharmaceuticals1 product
- Alvogen Inc.1 product
- RedPharm Drug, Inc.1 product
- NorthStar RxLLC1 product
- Creekwood Pharmaceuticals LLC1 product
- BluePoint Laboratories1 product
- Trigen Laboratories, LLC1 product
- Aurobindo Pharma Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020064 MACROBID | Almatica | December 24, 1991 | 20, latest March 2, 2023 2023: Manufacturing (CMC) · 2021: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (7)
- ANDA077066Sandoz · April 5, 2005
- ANDA207372Amneal Pharms · May 15, 2017
- ANDA208516Sunny · May 24, 2018
- ANDA211013Inventia · February 18, 2022
- ANDA209225Aurobindo Pharma · March 30, 2023
- ANDA217357Mankind Pharma · July 11, 2023
- ANDA220269Pharmazone · April 7, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: 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
-
July 24, 2019 · Class II · Terminated · D-1722-2019
Failed dissolution specifications
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01 — Alvogen, Inc
-
November 2, 2018 · Class III · Terminated · D-0257-2019
Cross Contamination with Other Products
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 0 — Sandoz Inc
-
April 21, 2015 · Class II · Terminated · D-1082-2015
Failed Dissolution Specification; 6 month time point
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01 — Alvogen, Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 539712, 1648755 |
|---|---|
| SPL set ID of the quoted label | 28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e |
| FDA labels (SPL) | 59 |
| FDA applications | NDA020064, 7 ANDA |
| Active ingredients (FDA) | NITROFURANTOIN / NITROFURANTOIN MONOHYDRATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Macrobid, Remedyrepack Inc., effective February 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →