Home NDC 0480-5425 Sorafenib
Product NDC 0480-5425
11-digit product format 004805425
Labeler code 0480
Product ID 0480-5425_213b5f06-be1f-4bc1-b09d-86c12f83d3b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sorafenib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA209567
Marketing category ANDA
Marketing start 2023-01-03
Substance SORAFENIB TOSYLATE
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 A209567-001 SORAFENIB TOSYLATE SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209567-001 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 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL 2020-11-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL 2020-11-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL 2020-11-12 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL 2020-11-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL 2020-11-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL 2020-11-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL 2020-11-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL 2020-11-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209567-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2020-11-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sorafenib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SORAFENIB TOSYLATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5T62Q3B36J 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0480-5425-89 Sorafenib 120 in 1 BOTTLE TABLET, FILM COATED 120 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-5425 SORAFENIB TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20230105_dae598f7-823f-405c-ae31-f924594187b9.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0480-5425-89 00480542589 120 TABLET, FILM COATED in 1 BOTTLE (0480-5425-89) 2023-01-03 0000-00-00 No No Current