FDA.reportPublic FDA data

MEKTOVI

Product NDC
70255-010
11-digit product format
702550010
Labeler code
70255
Product ID
70255-010_36941d95-638d-4a3c-8888-209eea0e0722
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BINIMETINIB
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Array BioPharma Inc.
Application
NDA210498
Marketing category
NDA
Marketing start
2018-06-27
Substance
BINIMETINIB
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MEKTOVI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BINIMETINIB15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii181R97MR71
Rxcui2049127, 2049133

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
5b9adbbd-c72a-4d00-8ea3-a322eb6e98b8Product name120180814
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70255-010-02MEKTOVI180 in 1 BOTTLETABLET, FILM COATED18012
70255-010-02MEKTOVI1 in 1 CARTONTABLET, FILM COATED112
70255-010-03MEKTOVI90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70255-010-02EA - Each70255-010165155c4-7d0f-4107-a7e5-f0f2add6611d12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70255-010MEKTOVI (BINIMETINIB) TABLET, FILM COATED [ARRAY BIOPHARMA INC.]12Current NDC, Legacy NDC, 3 package rows20250323_6c3408ac-d401-4925-8a03-26591afbc240.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049127binimetinib 15 MG Oral TabletPSN6c3408ac-d401-4925-8a03-26591afbc24012
2049133MEKTOVI 15 MG Oral TabletPSN6c3408ac-d401-4925-8a03-26591afbc24012
2049133binimetinib 15 MG Oral Tablet [Mektovi]SBD6c3408ac-d401-4925-8a03-26591afbc24012
2049127binimetinib 15 MG Oral TabletSCD6c3408ac-d401-4925-8a03-26591afbc24012
2049133Mektovi 15 MG Oral TabletSY6c3408ac-d401-4925-8a03-26591afbc24012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70255-010-02702550010021 BOTTLE in 1 CARTON (70255-010-02) / 180 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-06-270000-00-00NoNoCurrent
70255-010-037025500100390 TABLET, FILM COATED in 1 BOTTLE (70255-010-03) 2018-06-270000-00-00NoNoCurrent