Dofetilide (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 125 MCG (0.125 MG) 60 COUNT CONTAINER LABE L

Principal Display Panel — 125 mcg (0.125 mg) to count Container Label

NDC 42291- 411 -60

Dofetilide Capsules

125 mcg (0.125 mg)

PHARMACIST: Dispense the accompanying medication guide to each patient.

Rx Only

60 Capsules

Label 1
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 250 MCG (0.25 MG) 60 COUNT CONTAINER LABE L

Principal Display Panel — 250 mcg (0.25 mg) to count Container Label

NDC 42291- 412 -60

Dofetilide Capsules

250 mcg (0.25 mg)

PHARMACIST: Dispense the accompanying medication guide to each patient.

Rx Only

60 Capsules

Label 2
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 MCG (0.5 MG) 60 COUNT CONTAINER LABE L

Principal Display Panel — 500 mcg (0.5 mg) to count Container Label

NDC 42291- 413 -60

Dofetilide Capsules

500 mcg (0.5 mg)

PHARMACIST: Dispense the accompanying medication guide to each patient.

Rx Only

60 Capsules

Label 3
(click image for full-size original)
DOFETILIDE dofetilide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-411(NDC:42794-044)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOFETILIDE (DOFETILIDE) DOFETILIDE 125 ug
Inactive Ingredients
Ingredient Name Strength
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
MICROCRYSTALLINE CELLULOSE
STARCH, PREGELATINIZED CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
ANHYDROUS CITRIC ACID
COPOVIDONE
FD&C RED NO. 40
D&C YELLOW NO. 10
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
GELATIN
D&C RED NO. 28
AMMONIA
FERROSOFERRIC OXIDE
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 44
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-411-60 60 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207746 08/06/2018
DOFETILIDE dofetilide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-412(NDC:42794-045)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOFETILIDE (DOFETILIDE) DOFETILIDE 250 ug
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, PREGELATINIZED CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
ANHYDROUS CITRIC ACID
COPOVIDONE
FD&C RED NO. 40
D&C YELLOW NO. 10
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
GELATIN
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color pink (peach) , white Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-412-60 60 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207746 08/06/2018
DOFETILIDE dofetilide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-413(NDC:42794-046)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOFETILIDE (DOFETILIDE) DOFETILIDE 500 ug
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, PREGELATINIZED CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
ANHYDROUS CITRIC ACID
COPOVIDONE
FD&C RED NO. 40
D&C YELLOW NO. 10
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
GELATIN
AMMONIA
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color pink (peach) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 46
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-413-60 60 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207746 08/06/2018
Labeler — AvKARE, Inc. (796560394)

Revised: 08/2018 AvKARE, Inc.

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