Nitrofurantoin

Treats urinary tract infections due to susceptible strains of Escherichia coli…. Sold as Furadantin. Every FDA application for this active ingredient: 2 branded and 18 generic.

As of Nov 14, 2026, FDA lists 20 applications for Nitrofurantoin (sold as Furadantin), first approved Feb 6, 1953, with 2 new uses approved and 0 published complete response letters.

First approved: Feb 6, 1953
Applications: 20
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $31.4M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Nitrofurantoin	Part D	$31.4M	+21%	338,866

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

NITROFURANTOIN 25 MG/5 ML SUSP: $1.70 per MLGeneric · -37% in a year

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Nitrofurantoin Oral Suspension	To Be Discontinued	Apr 10, 2026	Apr 10, 2026

Clinical Trials

23 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study to Investigate Pivmecillinam Versus Nitrofurantoin in Female Adolescents 12 to Less Than 18 Years of Age With Uncomplicated Urinary Tract InfectionUncomplicated Urinary Tract Infections · Alembic Therapeutics	Phase 2	Not yet recruiting	Oct 13, 2026
Precision Management of Urinary Tract Symptoms in Older WomenUrinary Tract Infection (Diagnosis) · Megan Bradley	Phase 3	Recruiting	Jul 7, 2026
Self-Start Triage Model for Post-Botox® Lower Urinary Tract SymptomsOveractive Bladder · The Cleveland Clinic	Early phase 1	Recruiting	Jun 15, 2026
The Effect of Different Intra-canal Medications on Postoperative PainPulp Necrosis, Apical Periodontitis · Cairo University	Early phase 1	Recruiting	May 22, 2026
Prophylactic Antibiotics for Outpatient Urethral BulkingUrinary Tract Infections, Stress Urinary Incontinence · University of Miami	Phase 4	Recruiting	Mar 30, 2026
Randomized Controlled Trial of Different Antibiotic Duration Prior to Prostate Enucleation SurgeryBPH With Urinary Obstruction, Antibiotic Prophylaxis · Ohio State University	Phase 3	Not yet recruiting	Oct 6, 2025
Urine Alkalinization for UTI in Women: RCTUTI - Urinary Tract Infection · Assiut University	Not applicable	Not yet recruiting	Oct 2, 2025
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract InfectionChronic Urinary Tract Infection · University College, London	Phase 2	Recruiting	Oct 2, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 6, 1953	FuradantinNDA 8693 · New molecular entity	Procter And Gamble	14	Discontinued
Dec 23, 1953	FuradantinNDA 9175 · New dosage form	Casper Pharma LLC	27	Marketed
Sep 30, 1970	FuralanANDA 80017	Chartwell Molecular	1	Discontinued
Nov 25, 1970	NitrofurantoinANDA 80043	Sandoz	0	Discontinued
Nov 22, 1978	NitrofurantoinANDA 85796	Watson Labs	5	Discontinued
Dec 5, 1978	NitrofurantoinANDA 85797	Watson Labs	1	Discontinued
May 11, 2011	NitrofurantoinANDA 201679	Amneal Pharms	2	Discontinued
Aug 14, 2013	NitrofurantoinANDA 201355	Strides Pharma	2	Marketed
Sep 8, 2014	NitrofurantoinANDA 201693	Novel Labs Inc	1	Marketed
May 3, 2016	NitrofurantoinANDA 205180	Actavis Mid Atlantic	2	Marketed
Apr 14, 2023	NitrofurantoinANDA 216385	Novitium Pharma	1	Marketed
May 11, 2023	NitrofurantoinANDA 212607	Aurobindo Pharma	0	Marketed
Oct 28, 2024	NitrofurantoinANDA 218346	Biocon Pharma	0	Marketed
Jan 14, 2025	NitrofurantoinANDA 208909	Somerset Theraps LLC	0	Marketed
Jul 2, 2025	NitrofurantoinANDA 219495	Annora Pharma	0	Marketed
—	NitrofurantoinANDA 80003	Elkins Sinn	0	Discontinued
—	NitrofurantoinANDA 80078	Ivax Sub Teva Pharms	0	Discontinued
—	NitrofurantoinANDA 80447	Watson Labs	1	Discontinued
—	NitrofurantoinANDA 84085	Whiteworth Town Plsn	0	Discontinued
—	NitrofurantoinANDA 84326	Watson Labs	4	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA