FDA.reportPublic FDA data

Nexavar

Product NDC
50419-489
11-digit product format
504190489
Labeler code
50419
Product ID
50419-489_e597a26e-e04a-4f91-8c7c-a83243286396
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sorafenib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA021923
Marketing category
NDA
Marketing start
2023-10-02
Substance
SORAFENIB
Active strength
200 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], 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
Nexavar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SORAFENIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9ZOQ3TZI87
Rxcui597747, 615979

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33680929-c1c0-4a67-aa2e-1f98b8efd580Product name120240501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-489-01Nexavar120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12040

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-489-01EA - Each50419-4890ae7a0ae-4c30-4996-ae68-a53a2e4ae08612024-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SORAFENIBACTIVE INGREDIENT9ZOQ3TZI87NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22
SORAFENIBACTIVE MOIETY9ZOQ3TZI87NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-489NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]40Current NDC, 1 package rows20241116_b50667e4-5ebc-4968-a646-d605058dbef0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
615979NexAVAR 200 MG Oral TabletPSNb50667e4-5ebc-4968-a646-d605058dbef040
597747SORAfenib 200 MG Oral TabletPSNb50667e4-5ebc-4968-a646-d605058dbef040
615979sorafenib 200 MG Oral Tablet [Nexavar]SBDb50667e4-5ebc-4968-a646-d605058dbef040
597747sorafenib 200 MG Oral TabletSCDb50667e4-5ebc-4968-a646-d605058dbef040
615979Nexavar 200 MG Oral TabletSYb50667e4-5ebc-4968-a646-d605058dbef040
597747sorafenib (as sorafenib tosylate) 200 MG Oral TabletSYb50667e4-5ebc-4968-a646-d605058dbef040

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50419-489-0150419048901120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01) 2023-10-02NoNoHistorical