Quick answers
- What is Nitrofurantoin used for?
- The FDA-approved label (Nitrofurantoin, Rising Pharma Holdings, Inc., November 11, 2025) says: “Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcus species, Staphylococcus aureus, Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin oral suspension 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 have a boxed warning?
- No. None of the 49 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nitrofurantoin?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated April 10, 2026). Ask your pharmacist about alternatives.
- Has Nitrofurantoin been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started July 9, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Nitrofurantoin?
- 35 companies list prescription products of Nitrofurantoin in the FDA NDC Directory, including Proficient Rx LP, Bryant Ranch Prepack and Aurobindo Pharma Limited.
What Nitrofurantoin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcus species, Staphylococcus aureus, Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses […]. …
— FDA label: Nitrofurantoin, Rising Pharma Holdings, Inc., effective November 11, 2025. Read the full label on DailyMed →
The FDA has 49 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 49 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Suspension · For suspension |
|---|---|
| Route | Oral |
| Prescription products | 74 in the FDA NDC Directory |
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 100 mg capsule | Generic | $0.2561–$0.2719 per capsule 9 packages, lowest to highest |
| nitrofurantoin 25 mg capsule | Generic | $1.38 per capsule |
| nitrofurantoin 25 mg/5 mL for suspension | Generic | $1.70 per mL |
| nitrofurantoin 25 mg/5 mL suspension | Generic | $1.70 per mL |
| nitrofurantoin 50 mg capsule | Generic | $0.1762 per capsule |
| nitrofurantoin monohydrate 25 mg/5 mL suspension | Generic | $1.70 per mL |
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.
- Proficient Rx LP6 products
- Bryant Ranch Prepack5 products
- Aurobindo Pharma Limited4 products
- Alembic Pharmaceuticals Limited3 products
- BluePoint Labortories3 products
- Lifestar Pharma LLC3 products
- NorthStar RxLLC3 products
- A-S Medication Solutions3 products
- BluePoint Laboratories3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Alembic Pharmaceuticals Inc.3 products
- Lupin Pharmaceuticals, Inc.3 products
- Remedyrepack Inc.2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- AvPAK2 products
- American Health Packaging2 products
- Redpharm Drug2 products
- Zydus Lifesciences Limited2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Rising Pharma Holdings, Inc.2 products
- Verityrx, LLC1 product
- Micro Labs Limited1 product
- NuCare Pharmaceuticals, Inc.1 product
- Novel Laboratories, Inc.1 product
- Direct_Rx1 product
- Major Pharmaceuticals1 product
- Northwind Health Company, LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Somerset Therapeutics, LLC1 product
- Amneal Pharmaceuticals NY LLC1 product
- NorthStar Rx LLC1 product
- Biocon Pharma Inc.1 product
- ANI Pharmaceuticals, Inc.1 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 |
|---|---|---|---|
| NDA009175 FURADANTIN | Casper Pharma LLC | December 23, 1953 | 27, latest February 1, 2024 2024: Labeling · 2023: Manufacturing (CMC) · 2020: Labeling |
| NDA016620 MACRODANTIN | Almatica | June 5, 1970 | 45, latest January 21, 2021 2021: Labeling · 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC) |
Generic approvals (17)
- ANDA073652Impax Labs Inc · January 28, 1993
- ANDA073671Impax Labs Inc · January 28, 1993
- ANDA074967Aurobindo Pharma USA · July 9, 1997
- ANDA077025Aurobindo Pharma USA · August 18, 2004
- ANDA201679Amneal Pharms · May 11, 2011
- ANDA201693Novel Labs Inc · September 8, 2014
- ANDA201722Sun Pharm Industries · February 16, 2016
- ANDA205005Zydus Pharms · December 12, 2017
- ANDA203233Novel Labs Inc · July 9, 2018
- ANDA211935Alembic · June 25, 2021
- ANDA217272Mankind Pharma · March 21, 2023
- ANDA216385Novitium Pharma · April 14, 2023
- ANDA212607Aurobindo Pharma · May 11, 2023
- ANDA217073Micro Labs · November 3, 2023
- ANDA218346Biocon Pharma · October 28, 2024
- ANDA208909Somerset Theraps LLC · January 14, 2025
- ANDA219495Annora Pharma · July 2, 2025
Shortage status
To be discontinued · updated April 10, 2026 · first posted April 10, 2026
| Product | Nitrofurantoin, Oral Suspension, 25 mg/5 mL (NDC 69238-2512-9) |
|---|---|
| Company | Amneal Pharmaceuticals |
Ask your pharmacist whether your product is affected and what the options are.
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 9, 2024 · Class II · Terminated · D-0597-2024
Failed Dissolution Specifications
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarak — SUN PHARMACEUTICAL INDUSTRIES INC
-
December 21, 2018 · Class II · Terminated · D-0346-2019
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11. — LUPIN SOMERSET
-
June 28, 2018 · Class II · Terminated · D-0927-2018
Subpotent Drug and Failed Content Uniformity.
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, N — LUPIN SOMERSET
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nitrofurantoin, Rising Pharma Holdings, Inc., effective November 11, 2025; 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 →