NDC 70255-010

MEKTOVI

Binimetinib

MEKTOVI is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Array Biopharma Inc.. The primary component is Binimetinib.

• Product ID: 70255-010_6dc85178-e27c-4690-a594-c9ef8bea0ba2
• NDC: 70255-010
• Product Type: Human Prescription Drug
• Proprietary Name: MEKTOVI
• Generic Name: Binimetinib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-06-27
• Marketing Category: NDA / NDA
• Application Number: NDA210498
• Labeler Name: Array BioPharma Inc.
• Substance Name: BINIMETINIB
• Active Ingredient Strength: 15 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70255-010-02

1 BOTTLE in 1 CARTON (70255-010-02) > 180 TABLET, FILM COATED in 1 BOTTLE

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

NDC SPL Data Element Entries

NDC 70255-010-02 [70255001002]

MEKTOVI TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210498
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-27

NDC 70255-010-03 [70255001003]

MEKTOVI TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210498
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-06-27

Drug Details

Active Ingredients

Ingredient	Strength
BINIMETINIB	15 mg/1

OpenFDA Data

• SPL SET ID: 6c3408ac-d401-4925-8a03-26591afbc240
• Manufacturer:
  • Array BioPharma Inc.
• UNII:
  • 181R97MR71
• RxNorm Concept Unique ID - RxCUI:
  • 2049133
  • 2049127