acetylcysteine

FDA Drug Profile — Acetylcysteine

acetylcysteine is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand name including Acetylcysteine. Available dosage forms: powder, inhalant, injection, solution.

Drug Details

Generic Name
acetylcysteine
Brand Names
Acetylcysteine
Application Number
ANDA072547
Sponsor
Fujian South Pharmaceutical Co., Ltd.
NDC Codes
7
Dosage Forms
POWDER, INHALANT, INJECTION, SOLUTION
Routes
RESPIRATORY (INHALATION), INTRAVENOUS
Active Ingredients
ACETYLCYSTEINE

Indications and Usage

1 INDICATIONS AND USAGE Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI). Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with an acute ingestion or from repeated supratherapeutic ingestion (RSI) ( 1 ).