BRAFTOVI- encorafenib capsule

BRAFTOVI by

Drug Labeling and Warnings

BRAFTOVI by is a Prescription medication manufactured, distributed, or labeled by Array BioPharma Inc., Finorga. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack

EXP
Lot

BRAFTOVI® 50 mg

capsules
encorafenib

Pierre Fabre Médicament

XXXXX

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton

BRAFTOVI® 50 mg

hard capsules

encorafenib

Oral use

28 | hard capsules

Pierre Fabre
Médicament

INGREDIENTS AND APPEARANCE

BRAFTOVI 
encorafenib capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70255-050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENCORAFENIB (UNII: 8L7891MRB6) (ENCORAFENIB - UNII:8L7891MRB6)	ENCORAFENIB	50 mg

Inactive Ingredients
Ingredient Name	Strength
COPOVIDONE K25-31 (UNII: D9C330MD8B)
POLOXAMER 188 (UNII: LQA7B6G8JG)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCCINIC ACID (UNII: AB6MNQ6J6L)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	ORANGE (Swedish) , PINK (Biege)	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	A;LGX;50mg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70255-050-28	7 in 1 CARTON	03/01/2022
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		03/01/2022

Labeler - Array BioPharma Inc. (004047838)

Establishment
Name	Address	ID/FEI	Business Operations
Finorga		640422218	API MANUFACTURE(70255-050)