Nitazoxanide

FDA Drug Profile — Nitazoxanide

Nitazoxanide is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand name including Nitazoxanide. Available dosage forms: tablet, film coated, powder, tablet.

Drug Details

Generic Name
Nitazoxanide
Brand Names
Nitazoxanide
Application Number
ANDA213820
Sponsor
Rising Pharma Holdings, Inc.
NDC Codes
14
Dosage Forms
TABLET, FILM COATED, POWDER, TABLET
Routes
ORAL
Active Ingredients
NITAZOXANIDE

Indications and Usage

1 INDICATIONS AND USAGE Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum . Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2) ] . Nitazoxanide tablets are antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1 ). Limitations of Use: Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients (1).