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Data updated: Mar 10, 2026

MACRODANTIN

NITROFURANTOIN, MACROCRYSTALLINE
Infectious Disease Approved 1970-06-05
1
Indication
--
Phase 3 Trials
55
Years on Market

Details

Status
Prescription
First Approved
1970-06-05
Routes
ORAL
Dosage Forms
CAPSULE

Companies

MACRODANTIN Approval History

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What MACRODANTIN Treats

3 indications

MACRODANTIN is approved for 3 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Urinary Tract Infection
  • Pyelonephritis
  • Perinephric Abscess
Source: FDA Label

Drugs Similar to MACRODANTIN

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
NITROFURANTOIN
3 shared
Novartis
Shared indications:
Urinary Tract InfectionPyelonephritisPerinephric Abscess
AZACTAM
AZTREONAM
2 shared
Bristol-Myers Squibb
Shared indications:
Urinary Tract InfectionPyelonephritis
AZTREONAM
AZTREONAM
2 shared
Pfizer
Shared indications:
Urinary Tract InfectionPyelonephritis
CEFEPIME HYDROCHLORIDE
CEFEPIME HYDROCHLORIDE
2 shared
QILU ANTIBIOTICS
Shared indications:
Urinary Tract InfectionPyelonephritis
AMOXICILLIN PEDIATRIC
AMOXICILLIN
1 shared
Teva
Shared indications:
Urinary Tract Infection
AMPICILLIN SODIUM
AMPICILLIN SODIUM
1 shared
SAGENT PHARMS INC
Shared indications:
Urinary Tract Infection
ANCOBON
FLUCYTOSINE
1 shared
BAUSCH
Shared indications:
Urinary Tract Infection
ARIKAYCE KIT
AMIKACIN SULFATE
1 shared
INSMED INC
Shared indications:
Urinary Tract Infection
AUGMENTIN '125'
AMOXICILLIN
1 shared
US ANTIBIOTICS
Shared indications:
Urinary Tract Infection
AUGMENTIN '250'
AMOXICILLIN
1 shared
US ANTIBIOTICS
Shared indications:
Urinary Tract Infection
AUGMENTIN '875'
AMOXICILLIN
1 shared
US ANTIBIOTICS
Shared indications:
Urinary Tract Infection
AUGMENTIN XR
AMOXICILLIN
1 shared
US ANTIBIOTICS
Shared indications:
Urinary Tract Infection
AVYCAZ
AVIBACTAM SODIUM
1 shared
AbbVie
Shared indications:
Pyelonephritis
BACTRIM
SULFAMETHOXAZOLE
1 shared
Sun Pharma
Shared indications:
Urinary Tract Infection
BACTRIM DS
SULFAMETHOXAZOLE
1 shared
Sun Pharma
Shared indications:
Urinary Tract Infection
BLUJEPA
GEPOTIDACIN MESYLATE
1 shared
GSK
Shared indications:
Urinary Tract Infection
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
CEFEPIME HYDROCHLORIDE
1 shared
B BRAUN
Shared indications:
Urinary Tract Infection
CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER
CEFEPIME HYDROCHLORIDE
1 shared
SAMSON MEDCL
Shared indications:
Urinary Tract Infection
CEFEPIME IN PLASTIC CONTAINER
CEFEPIME HYDROCHLORIDE
1 shared
Baxter
Shared indications:
Urinary Tract Infection
CEFOTAN
CEFOTETAN DISODIUM
1 shared
PAI HOLDINGS PHARM
Shared indications:
Urinary Tract Infection
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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MACRODANTIN FDA Label Details

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Indications & Usage

FDA Label (PDF)

Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli , enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible ...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.