FDA.reportPublic FDA data

Stivarga

Product NDC
50419-171
11-digit product format
504190171
Labeler code
50419
Product ID
50419-171_8f47fb28-9855-4482-b807-e98c425c2a4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
regorafenib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA203085
Marketing category
NDA
Marketing start
2012-09-27
Substance
REGORAFENIB
Active strength
40 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], UGT1A1 Inhibitors [MoA], UGT1A9 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REGORAFENIB40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMGN125FS9D
Rxcui1312402, 1312408

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
9df16c21-ce0c-4fa9-b0f8-65e8606957c4Product name120170706
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
50419-171-00Stivarga28 in 1 BOTTLETABLET, FILM COATED2836
50419-171-00Stivarga210 in 1 BOXTABLET, FILM COATED21036
50419-171-01Stivarga28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2836
50419-171-03Stivarga3 in 1 BOXTABLET, FILM COATED336
50419-171-04Stivarga1 in 1 CARTONTABLET, FILM COATED136
50419-171-04Stivarga28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2836
50419-171-05Stivarga21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2136
50419-171-06Stivarga4 in 1 CARTONTABLET, FILM COATED436

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-171-01EA - Each50419-171e5f07a51-1931-4646-b9a2-86ab7633a68412013-02-13
50419-171-03EA - Each50419-17104591752-7d5d-48a0-8c07-50c2101e768312013-02-13
50419-171-05EA - Each50419-171775f0959-7f06-47c5-bbb7-e03e1957c30712021-02-05
50419-171-06EA - Each50419-1714c500246-394b-4549-9cf6-ca207217b2ba12021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
REGORAFENIB MONOHYDRATEACTIVE INGREDIENTMGN125FS9DSTIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
REGORAFENIBACTIVE MOIETY24T2A1DOYBSTIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSTIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PSTIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
POVIDONESINACTIVE INGREDIENTFZ989GH94ESTIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
TALCINACTIVE INGREDIENT7SEV7J4R1USTIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-171STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]35Current NDC, Legacy NDC, 8 package rows20250309_824f19c9-0546-4a8a-8d8f-c4055c04f7c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1312402regorafenib 40 MG Oral TabletPSN824f19c9-0546-4a8a-8d8f-c4055c04f7c736
1312408Stivarga 40 MG Oral TabletPSN824f19c9-0546-4a8a-8d8f-c4055c04f7c736
1312408regorafenib 40 MG Oral Tablet [Stivarga]SBD824f19c9-0546-4a8a-8d8f-c4055c04f7c736
1312402regorafenib 40 MG Oral TabletSCD824f19c9-0546-4a8a-8d8f-c4055c04f7c736
1312408Stivarga 40 MG Oral TabletSY824f19c9-0546-4a8a-8d8f-c4055c04f7c736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-171-0050419017100210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE210 bottle2012-09-270000-00-00NoNoCurrent
50419-171-015041901710128 in 1 BOTTLE, PLASTICHistorical
50419-171-03504190171033 BOTTLE, PLASTIC in 1 BOX (50419-171-03) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01) 2012-09-270000-00-00NoNoCurrent
50419-171-04504190171041 BOTTLE, PLASTIC in 1 CARTON (50419-171-04) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2012-09-270000-00-00NoNoCurrent
50419-171-055041901710521 in 1 BOTTLE, PLASTICHistorical
50419-171-06504190171064 BOTTLE, PLASTIC in 1 CARTON (50419-171-06) / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05) 2021-05-010000-00-00NoNoCurrent