NDC 70255-020

BRAFTOVI

Encorafenib

BRAFTOVI is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Array Biopharma Inc.. The primary component is Encorafenib.

• Product ID: 70255-020_026d5ada-5db2-468c-a035-69669558c8b0
• NDC: 70255-020
• Product Type: Human Prescription Drug
• Proprietary Name: BRAFTOVI
• Generic Name: Encorafenib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-27
• Marketing Category: NDA / NDA
• Application Number: NDA210496
• Labeler Name: Array BioPharma Inc.
• Substance Name: ENCORAFENIB
• Active Ingredient Strength: 50 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70255-020-01

2 BOTTLE in 1 CARTON (70255-020-01) > 60 CAPSULE in 1 BOTTLE (70255-020-02)

• Marketing Start Date: 2018-06-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70255-020-02 [70255002002]

BRAFTOVI CAPSULE

• Marketing Category: NDA
• Application Number: NDA210496
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-27
• Marketing End Date: 2019-03-13

NDC 70255-020-01 [70255002001]

BRAFTOVI CAPSULE

• Marketing Category: NDA
• Application Number: NDA210496
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-27
• Marketing End Date: 2019-03-13

Drug Details

Active Ingredients

Ingredient	Strength
ENCORAFENIB	50 mg/1

OpenFDA Data

• SPL SET ID: 235dfc38-0f0b-4037-b501-7a9f4294740c
• Manufacturer:
  • Array BioPharma Inc.
• UNII:
  • 8L7891MRB6
• RxNorm Concept Unique ID - RxCUI:
  • 2049121
  • 2049117
  • 2049111
  • 2049119

NDC Crossover Matching brand name "BRAFTOVI" or generic name "Encorafenib"

NDC	Brand Name	Generic Name
70255-020	BRAFTOVI	Encorafenib
70255-025	BRAFTOVI	Encorafenib