ondansetron hydrochloride

FDA Drug Profile — ondansetron hydrochloride, ondansetron, Ondansetron

ondansetron hydrochloride is listed in the FDA National Drug Code directory with 16 NDC codes, marketed under brand names including ondansetron hydrochloride, ondansetron, Ondansetron. Available dosage forms: tablet, film coated, solution, injection, solution, injection.

Drug Details

Generic Name
ondansetron hydrochloride
Brand Names
ondansetron hydrochloride, ondansetron, Ondansetron
Application Number
ANDA076183
Sponsor
NCS HealthCare of KY, LLC dba Vangard Labs
NDC Codes
16
Dosage Forms
TABLET, FILM COATED, SOLUTION, INJECTION, SOLUTION, INJECTION
Routes
ORAL, INTRAMUSCULAR, INTRAVENOUS
Active Ingredients
ONDANSETRON HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are a 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . (1) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (1) nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (1) postoperative nausea and/or vomiting. (1)