Home NDC 50419-489 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 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 N021923-001 NEXAVAR SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021923-001 AB
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 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20
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 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL RLD, RS 2005-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL RLD, RS 2005-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL RLD, RS 2005-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL RLD, RS 2005-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL RLD, RS 2005-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL RLD, RS 2005-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL RLD, RS 2005-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL RLD, RS 2005-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL RLD, RS 2005-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021923-001 NEXAVAR EQ 200MG BASE TABLET / ORAL AB RLD, RS 2005-12-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 218 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 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021923-001 8877933 2027-12-24 U-1624 Drug substance, Drug product 2014-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021923-001 9737488 2028-09-10 U-2107 Drug product 2017-09-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021923-001 9737488 2028-09-10 U-1480 Drug product 2017-09-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021923-001 9737488 2028-09-10 U-1696 Drug product 2017-09-20 d06236e962d9…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Nexavar
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SORAFENIB 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9ZOQ3TZI87 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 597747 Internal RxNorm lookup 615979 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 50419-489-01 Nexavar 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 40
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SORAFENIB ACTIVE INGREDIENT 9ZOQ3TZI87 NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 SORAFENIB ACTIVE MOIETY 9ZOQ3TZI87 NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-489 NEXAVAR (SORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 40 Current NDC, 1 package rows 20241116_b50667e4-5ebc-4968-a646-d605058dbef0.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 Nexavar SORAFENIB Bayer HealthCare Pharmaceuticals Inc. b50667e4-5ebc-4968-a646-d605058dbef0 2023-08-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 021923 application number: NDA021923 ndc (product): 50419-489
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50419-489-01 50419048901 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01) 2023-10-02 No No Current