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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 073664

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NDA 073664 describes ACETYLCYSTEINE, which is a drug marketed by Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Onesource Specialty, Regcon Holdings, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Zydus Pharms, Alvogen, Am Regent, Conba Usa, Hospira, and Roxane, and is included in twenty-five NDAs. It is available from twelve suppliers. Additional details are available on the ACETYLCYSTEINE profile page.

The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for 073664

Tradename:	ACETYLCYSTEINE
Applicant:	Hospira
Ingredient:	acetylcysteine
Patents:	0

Pharmacology for NDA: 073664

Mechanism of Action	Reduction Activity
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration

Medical Subject Heading (MeSH) Categories for 073664

Antiviral Agents
Expectorants
Free Radical Scavengers

Suppliers and Packaging for NDA: 073664

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	073664	ANDA	Hospira, Inc.	0409-3307	0409-3307-03	3 VIAL in 1 CARTON (0409-3307-03) / 30 mL in 1 VIAL (0409-3307-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION, ORAL			Strength	10%
Approval Date:	Aug 30, 1994	TE:	AN	RLD:	No

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