FDA.reportPublic FDA data

NDC 50419-171-01 - Stivarga

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50419-171
Requested NDC
50419-171-01
Package NDCs from labels
50419-171-01, 50419-171-03, 50419-171-00, 50419-171-04, 50419-171-05, 50419-171-06
Manufacturer
Bayer HealthCare Pharmaceuticals Inc. | Sharp Corporation | Bayer AG
Effective date
2026-02-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Stivarga - Bayer HealthCare Pharmaceuticals Inc. | Sharp Corporation | Bayer AGBayer HealthCare Pharmaceuticals Inc. | Sharp Corporation | Bayer AG2026-02-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 142 · 2,840 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mix-In Laxative PacketsPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc0347c934-1e85-4f8d-8d35-bb07f16810ad2026-08-27WarningsExact identifier
unii: G2M7P15E5P
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.