FDA.reportPublic FDA data

BRAFTOVI

Product NDC
70255-025
11-digit product format
702550025
Labeler code
70255
Product ID
70255-025_7dd6ed01-4c55-49ef-b55d-6d82c5dfc02e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Encorafenib
Dosage form
CAPSULE
Route
ORAL
Labeler
Array BioPharma Inc.
Application
NDA210496
Marketing category
NDA
Marketing start
2018-06-27
Substance
ENCORAFENIB
Active strength
75 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BRAFTOVI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENCORAFENIB75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8L7891MRB6
Rxcui2049119, 2049121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51b3bf3a-1f06-4bd0-a212-a14975d8149aProduct name120180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70255-025-01BRAFTOVI2 in 1 CARTONCAPSULE223
70255-025-02BRAFTOVI90 in 1 BOTTLECAPSULE9023
70255-025-03BRAFTOVI2 in 1 CARTONCAPSULE223
70255-025-04BRAFTOVI60 in 1 BOTTLECAPSULE6023
70255-025-05BRAFTOVI90 in 1 BOTTLECAPSULE9023
70255-025-06BRAFTOVI60 in 1 BOTTLECAPSULE6023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70255-025-01EA - Each70255-02593fe5fcb-7a34-4b73-b24c-c4c1136675bb12018-08-13
70255-025-02EA - Each70255-025d7ba99cc-59fc-4233-8346-5fe07b325a2112018-08-13
70255-025-03EA - Each70255-025f7bc5a5c-64e9-4ce3-8298-eb3d74485bc212019-07-02
70255-025-04EA - Each70255-025176b6722-6307-4b31-80cc-030f0492e5d812019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70255-025BRAFTOVI (ENCORAFENIB) CAPSULE [ARRAY BIOPHARMA INC.]21Current NDC, Legacy NDC, 6 package rows20250418_235dfc38-0f0b-4037-b501-7a9f4294740c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049121BRAFTOVI 75 MG Oral CapsulePSN235dfc38-0f0b-4037-b501-7a9f4294740c23
2049119encorafenib 75 MG Oral CapsulePSN235dfc38-0f0b-4037-b501-7a9f4294740c23
2049121encorafenib 75 MG Oral Capsule [Braftovi]SBD235dfc38-0f0b-4037-b501-7a9f4294740c23
2049119encorafenib 75 MG Oral CapsuleSCD235dfc38-0f0b-4037-b501-7a9f4294740c23
2049121Braftovi 75 MG Oral CapsuleSY235dfc38-0f0b-4037-b501-7a9f4294740c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70255-025-01702550025012 BOTTLE in 1 CARTON (70255-025-01) / 90 CAPSULE in 1 BOTTLE (70255-025-02) 2 bottle2018-06-270000-00-00NoNoCurrent
70255-025-027025500250290 in 1 BOTTLEHistorical
70255-025-03702550025032 BOTTLE in 1 CARTON (70255-025-03) / 60 CAPSULE in 1 BOTTLE (70255-025-04) 2 bottle2018-06-270000-00-00NoNoCurrent
70255-025-047025500250460 in 1 BOTTLEHistorical
70255-025-057025500250590 CAPSULE in 1 BOTTLE (70255-025-05) 90 capsule2020-08-030000-00-00NoNoCurrent
70255-025-067025500250660 CAPSULE in 1 BOTTLE (70255-025-06) 60 capsule2020-08-030000-00-00NoNoCurrent