;HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-7464
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
BENZNIDAZOLE (UNII: YC42NRJ1ZD) (BENZNIDAZOLE - UNII:YC42NRJ1ZD) BENZNIDAZOLE 100 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
PRODUCT CHARACTERISTICS
Color WHITE Score 4 pieces
Shape ROUND Size 10mm
Flavor Imprint Code E
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0642-7464-10 1 in 1 CARTON 03/30/2018
1 100 in 1 BOTTLE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209570 03/30/2018
BENZNIDAZOLE
benznidazole tablet
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-7463
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
BENZNIDAZOLE (UNII: YC42NRJ1ZD) (BENZNIDAZOLE - UNII:YC42NRJ1ZD) BENZNIDAZOLE 12.5 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
PRODUCT CHARACTERISTICS
Color WHITE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code E
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0642-7463-12 1 in 1 CARTON 03/30/2018
1 100 in 1 BOTTLE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209570 03/30/2018
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