Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205005

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NDA 205005 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Alembic, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Pom Pharma, Sun Pharm Industries, Watson Labs, Zydus Pharms, Actavis Mid Atlantic, Amneal Pharms, Annora Pharma, Aurobindo Pharma, Biocon Pharma, Novitium Pharma, Somerset Theraps Llc, Strides Pharma, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Alvogen, Chartwell Rx, Creekwood Pharms, Inventia, Omsav Pharma, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in forty-three NDAs. It is available from thirty-four suppliers. Additional details are available on the NITROFURANTOIN profile page.

The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for 205005

Tradename:	NITROFURANTOIN
Applicant:	Zydus Pharms
Ingredient:	nitrofurantoin, macrocrystalline
Patents:	0

Pharmacology for NDA: 205005

Suppliers and Packaging for NDA: 205005

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	205005	ANDA	Major Pharmaceuticals	0904-7026	0904-7026-61	100 BLISTER PACK in 1 CARTON (0904-7026-61) / 1 CAPSULE in 1 BLISTER PACK
NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	205005	ANDA	Zydus Pharmaceuticals (USA) Inc.	68382-559	68382-559-01	100 CAPSULE in 1 BOTTLE (68382-559-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Dec 12, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Dec 12, 2017	TE:	AB	RLD:	No

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