Ondansetron tablet, orally disintegrating

Ingredients and appearance - Product information

Ondansetron tablet, orally disintegrating- Ondansetron

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 33261-747
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ondansetron ( UNII: 4AF302ESOS)( Ondansetron - UNII: 4AF302ESOS ) 4 mgin 1

Inactive Ingredients

Ingredient Name Code
Aspartame ( UNII: Z0H242BBR1)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Crospovidone ( UNII: 68401960MK)
Magnesium stearate ( UNII: 70097M6I30)
Mannitol ( UNII: 3OWL53L36A)
Sodium stearyl fumarate ( UNII: 7CV7WJK4UI)

Product Characteristics

Color WHITE Flavor STRAWBERRY
Imprint Code G;4 Score 1
Shape ROUND Size 7 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078152 USA

Ondansetron tablet, orally disintegrating- Ondansetron

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 33261-761
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ondansetron ( UNII: 4AF302ESOS)( Ondansetron - UNII: 4AF302ESOS ) 8 mgin 1

Inactive Ingredients

Ingredient Name Code
Aspartame ( UNII: Z0H242BBR1)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Crospovidone ( UNII: 68401960MK)
Magnesium stearate ( UNII: 70097M6I30)
Mannitol ( UNII: 3OWL53L36A)
Sodium stearyl fumarate ( UNII: 7CV7WJK4UI)

Product Characteristics

Color WHITE Flavor STRAWBERRY
Imprint Code G;8 Score 1
Shape ROUND Size 8 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078152 USA

Labeler - Aidarex Pharmaceuticals LLC( 801503249)

The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8 mg ondansetron tablet was administered twice a day for 2 days after completion of chemotherapy.
Median undefined since at least 50% of the patients were withdrawn or had more than 2 emetic episodes.
Median undefined since at least 50% of patients did not have any emetic episodes.
The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8-mg ondansetron tablet was administered twice a day for 2 days after completion of chemotherapy.
The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. An 8-mg ondansetron tablet was administered 3 times a day for 2 days after completion of chemotherapy.
Median undefined since at least 50% of patients did not have any emetic episodes.
Visual analog scale assessment: 0 = no nausea, 100 = nausea as bad as it can be.