gth
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code M;NE;30
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0378-0353-93 30 TABLET In 1 BOTTLE, PLASTIC None
2 0378-0353-01 100 TABLET In 1 BOTTLE, PLASTIC None
3 0378-0353-10 1000 TABLET In 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201071 12/06/2010
NIFEDIPINE
nifedipine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0378-0360
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE (NIFEDIPINE) NIFEDIPINE 60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
TRIACETIN
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code M;NE;60
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0378-0360-93 30 TABLET In 1 BOTTLE, PLASTIC None
2 0378-0360-01 100 TABLET In 1 BOTTLE, PLASTIC None
3 0378-0360-10 1000 TABLET In 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201071 12/06/2010
NIFEDIPINE
nifedipine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0378-0390
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIFEDIPINE (NIFEDIPINE) NIFEDIPINE 90 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C RED NO. 27
FD&C BLUE NO. 2
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
TRIACETIN
FD&C RED NO. 40
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9mm
Flavor Imprint Code M;NE;90
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0378-0390-93 30 TABLET In 1 BOTTLE, PLASTIC None
2 0378-0390-01 |
