Ondansetron

Product manufactured by Cardinal Health

Application Nr Approved Date Route Status External Links
ANDA076930 2007-06-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage •prevention Of Nausea And Vomiting Associated With Highly Emetogenic Cancer Chemotherapy, Including Cisplatin ≥ 50 Mg/m2. •prevention Of Nausea And Vomiting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy. •prevention Of 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. •prevention Of Postoperative Nausea And/or Vomiting. As With Other Antiemetics, Routine Prophylaxis Is Not Recommended For Patients In Whom There Is Little Expectation That Nausea And/or Vomiting Will Occur Postoperatively. In Patients Where Nausea And/or Vomiting Must Be Avoided Postoperatively, Ondansetron Tablets Are Recommended Even Where The Incidence Of Postoperative Nausea And/or Vomiting Is Low.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE ZINC4448

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