FDA.reportPublic FDA data

ZELBORAF

Product NDC
50242-090
11-digit product format
502420090
Labeler code
50242
Product ID
50242-090_77f36fc9-7ae6-425a-9dff-79ab4476c864
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vemurafenib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA202429
Marketing category
NDA
Marketing start
2011-08-17
Substance
VEMURAFENIB
Active strength
240 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VEMURAFENIB240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii207SMY3FQT
Rxcui1147223, 1147228

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
badacb45-60f3-db9d-c255-c20cd7f008d2Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-090-02ZELBORAF112 in 1 BOTTLE, PLASTICTABLET, FILM COATED11228
50242-090-02ZELBORAF1 in 1 CARTONTABLET, FILM COATED128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-090-01EA - Each50242-0906b39b0b6-1a45-4837-a712-f560aef12de212012-07-24
50242-090-02EA - Each50242-09067b47fdc-f712-4271-b392-6eacfa6dab0f12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VemurafenibACTIVE INGREDIENT207SMY3FQTZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
VemurafenibACTIVE MOIETY207SMY3FQTZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
Ferric oxide redINACTIVE INGREDIENT1K09F3G675ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
Hydroxypropyl cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
Hypromellose acetate succinate 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
Magnesium StearateINACTIVE INGREDIENT70097M6I30ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
Polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
Polyvinyl alcoholINACTIVE INGREDIENT532B59J990ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
Silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
TalcINACTIVE INGREDIENT7SEV7J4R1UZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-090ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.]26Current NDC, Legacy NDC, 2 package rows20241123_38eea320-7e0c-485a-bc30-98c3c45e2763.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147223vemurafenib 240 MG Oral TabletPSN38eea320-7e0c-485a-bc30-98c3c45e276328
1147228Zelboraf 240 MG Oral TabletPSN38eea320-7e0c-485a-bc30-98c3c45e276328
1147228vemurafenib 240 MG Oral Tablet [Zelboraf]SBD38eea320-7e0c-485a-bc30-98c3c45e276328
1147223vemurafenib 240 MG Oral TabletSCD38eea320-7e0c-485a-bc30-98c3c45e276328
1147228Zelboraf 240 MG Oral TabletSY38eea320-7e0c-485a-bc30-98c3c45e276328

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-090-02502420090021 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2015-09-080000-00-00NoNoCurrent
50242-090-86502420090861 BOTTLE, PLASTIC in 1 CARTON (50242-090-86) > 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2014-04-100000-00-00YesNoCurrent