Home NDC 50419-171 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203085-001 STIVARGA REGORAFENIB 40MG TABLET / ORAL RLD, RS 2012-09-27
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203085-001 8680124 2030-06-02 U-1506 2014-04-21 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 STIVARGA 40MG TABLET / ORAL AB RLD, RS 2012-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 STIVARGA 40MG TABLET / ORAL AB RLD, RS 2012-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203085-001 STIVARGA 40MG TABLET / ORAL RLD, RS 2012-09-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 AB 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 AB 1 b8a1b40f171c…
Observed Orange Book patent history# Patent history page 1 of 5 · 182 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203085-001 8680124 2030-06-02 U-1506 2014-04-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203085-001 8637553 2031-02-16 Drug substance, Drug product 2014-02-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203085-001 9458107 2031-04-08 Drug product 2016-11-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203085-001 9957232 2032-07-09 Drug substance 2018-05-30 d06236e962d9…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 47 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Stivarga
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REGORAFENIB 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MGN125FS9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1312402 Internal RxNorm lookup 1312408 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50419-171-00 Stivarga 28 in 1 BOTTLE TABLET, FILM COATED 28 36 50419-171-00 Stivarga 210 in 1 BOX TABLET, FILM COATED 210 36 50419-171-01 Stivarga 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 36 50419-171-03 Stivarga 3 in 1 BOX TABLET, FILM COATED 3 36 50419-171-04 Stivarga 1 in 1 CARTON TABLET, FILM COATED 1 36 50419-171-04 Stivarga 28 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 28 36 50419-171-05 Stivarga 21 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 21 36 50419-171-06 Stivarga 4 in 1 CARTON TABLET, FILM COATED 4 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded REGORAFENIB MONOHYDRATE ACTIVE INGREDIENT MGN125FS9D STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 REGORAFENIB ACTIVE MOIETY 24T2A1DOYB STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 POVIDONES INACTIVE INGREDIENT FZ989GH94E STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 TALC INACTIVE INGREDIENT 7SEV7J4R1U STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-171 STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 35 Current NDC, Legacy NDC, 8 package rows 20250309_824f19c9-0546-4a8a-8d8f-c4055c04f7c7.zip
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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stivarga REGORAFENIB Bayer HealthCare Pharmaceuticals Inc. 824f19c9-0546-4a8a-8d8f-c4055c04f7c7 2026-02-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 203085 application number: NDA203085 ndc (product): 50419-171
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-171-00 50419017100 210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE 210 bottle 2012-09-27 0000-00-00 No No Current 50419-171-01 50419017101 28 in 1 BOTTLE, PLASTIC Historical 50419-171-03 50419017103 3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01) 2012-09-27 0000-00-00 No No Current 50419-171-04 50419017104 1 BOTTLE, PLASTIC in 1 CARTON (50419-171-04) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2012-09-27 0000-00-00 No No Current 50419-171-05 50419017105 21 in 1 BOTTLE, PLASTIC Historical 50419-171-06 50419017106 4 BOTTLE, PLASTIC in 1 CARTON (50419-171-06) / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05) 2021-05-01 0000-00-00 No No Current