Label: BRAFTOVI- encorafenib capsule
- NDC Code(s): 70255-050-28
- Packager: Array BioPharma Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated July 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack
- PRINCIPAL DISPLAY PANEL - 50 mg Capsule Blister Pack Carton
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INGREDIENTS AND APPEARANCE
BRAFTOVI
encorafenib capsuleProduct 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)
