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Active ingredient

Nitrofurantoin

139 finished FDA listings contain Nitrofurantoin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
NITROFURANTOIN, NITROFURANTOIN MONOHYDRATE
Dosage forms
Capsule, For Suspension, Suspension
Routes
Oral
Manufacturers / labelers
35
Strengths listed
100 mg/1 · 25 mg/1 · 25 mg/5ml · 50 mg/1 · 50 mg/5ml
Brand names in FDA listings
Nitrofurantoin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7454

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 009175CASPER PHARMA LLC1953-12-231
NDA 016620ALMATICA1970-06-053
ANDA 073671IMPAX LABS INC1993-01-282
ANDA 073652IMPAX LABS INC1993-01-286
ANDA 074967AUROBINDO PHARMA USA1997-07-091
ANDA 077025AUROBINDO PHARMA USA2004-08-183
ANDA 201679AMNEAL PHARMS2011-05-112
ANDA 201693NOVEL LABS INC2014-09-082
ANDA 201722SUN PHARM INDUSTRIES2016-02-1610
ANDA 205005ZYDUS PHARMS2017-12-126
ANDA 203233NOVEL LABS INC2018-07-092
ANDA 211935ALEMBIC2021-06-258
ANDA 217272MANKIND PHARMA2023-03-2121
ANDA 216385NOVITIUM PHARMA2023-04-142
ANDA 212607AUROBINDO PHARMA2023-05-112
ANDA 217073MICRO LABS2023-11-031
ANDA 218346BIOCON PHARMA2024-10-281
ANDA 208909SOMERSET THERAPS LLC2025-01-141
ANDA 219495ANNORA PHARMA2025-07-021

Official labeling on DailyMed

Showing the 12 most recent of 53 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.