Tafinlar (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

NDC 0078-0682-66

Tafinlar® (Dabrafenib) Capsules

50 mg

Rx only

120 Capsules

Dispense with Medication Guide attached or provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
								NDC 0078-0682-66
								Tafinlar® (Dabrafenib) Capsules
								50 mg
								Rx only
								120 Capsules
								Dispense with Medication Guide attached or provided separately.
								NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0681-66

Tafinlar® (Dabrafenib) Capsules

75 mg

Rx only

120 Capsules

Dispense with Medication Guide attached or provided separately.

NOVARTIS

PRINCIPAL DISPLAY PANEL
								NDC 0078-0681-66
								Tafinlar® (Dabrafenib) Capsules
								75 mg
								Rx only
								120 Capsules
								Dispense with Medication Guide attached or provided separately.
								NOVARTIS
(click image for full-size original)
TAFINLAR dabrafenib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0682
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DABRAFENIB MESYLATE (DABRAFENIB) DABRAFENIB 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape OVAL Size 18mm
Flavor Imprint Code GSTEW;50mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0682-66 120 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202806 04/12/2016
TAFINLAR dabrafenib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0681
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DABRAFENIB MESYLATE (DABRAFENIB) DABRAFENIB 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape OVAL Size 20mm
Flavor Imprint Code GSLHF;75mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0681-66 120 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202806 04/01/2016
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2021 Novartis Pharmaceuticals Corporation

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