ondansetron

FDA Drug Profile — ondansetron

ondansetron is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand name including ondansetron. Available dosage forms: tablet, orally disintegrating, injection, powder.

Drug Details

Generic Name
ondansetron
Brand Names
ondansetron
Application Number
ANDA077557
Sponsor
NuCare Pharmaceuticals,Inc.
NDC Codes
7
Dosage Forms
TABLET, ORALLY DISINTEGRATING, INJECTION, POWDER
Routes
ORAL, INTRAMUSCULAR, INTRAVENOUS
Active Ingredients
ONDANSETRON

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 )