Home NDC 51990-201 sorafenib
Product NDC 51990-201
11-digit product format 519900201
Labeler code 51990
Product ID 51990-201_4685d90a-e8e2-5c01-e063-6294a90a1439
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sorafenib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Yabao Pharmaceutical Co., Ltd. Beijing
Application ANDA209050
Marketing category ANDA
Marketing start 2022-12-01
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 A209050-001 SORAFENIB TOSYLATE SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209050-001 AB
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.
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 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209050-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2022-11-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base sorafenib
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 597747 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 51990-201-06 2024-02-18 These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 51990-201-06 2024-02-18 These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 51990-201-12 2024-02-18 These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 51990-201-12 2024-02-18 These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 51990-201-06 2024-01-30 These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 51990-201-06 2024-01-30 These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 51990-201-12 2024-01-30 These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005 51990-201-12 2024-01-30 These highlights do not include all the information needed to use SORAFENIB TABLETS safely and effectively. See full prescribing information for SORAFENIB TABLETS. Sorafenib tablets, for oral use Initial U.S. Approval: 2005
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51990-201-06 sorafenib 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 9 51990-201-12 sorafenib 120 in 1 PACKAGE TABLET, FILM COATED 120 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51990-201 SORAFENIB TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] 7 Current NDC, Legacy NDC, 2 package rows 20241208_06f442d6-071e-4081-b7f7-40f3b803ab3f.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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51990-201-06 51990020106 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51990-201-06) 2022-12-01 0000-00-00 No No Current 51990-201-12 51990020112 120 TABLET, FILM COATED in 1 PACKAGE (51990-201-12) 2022-12-01 0000-00-00 No No Current