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 9 of 142 · 2,840 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
GAVILAXPOLYETHYLENE GLYCOL 3350Atlantic Biologicals Corp.4c207478-6f0f-c3cf-e063-6394a90aa4f22026-06-04WarningsExact identifier
unii: G2M7P15E5P
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
unii: 15FIX9V2JP
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
unii: 1K09F3G675
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: 15FIX9V2JP
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
unii: 15FIX9V2JP
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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