Home NDC 13668-682 Sorafenib
Product NDC 13668-682
11-digit product format 136680682
Labeler code 13668
Product ID 13668-682_27389dc4-60cc-4c65-92e6-97bcc09f7d20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sorafenib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA217095
Marketing category ANDA
Marketing start 2023-04-12
Substance SORAFENIB
Active strength 200 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Protein Kinase 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 A217095-001 SORAFENIB TOSYLATE SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217095-001 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 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217095-001 SORAFENIB TOSYLATE EQ 200MG BASE TABLET / ORAL AB 2023-04-12 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13668-682-12 Sorafenib 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 5 13668-682-30 Sorafenib 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 5 13668-682-60 Sorafenib 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 5 13668-682-74 Sorafenib 10 in 1 CARTON TABLET, FILM COATED 10 5 13668-682-74 Sorafenib 10 in 1 BLISTER PACK TABLET, FILM COATED 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-682 SORAFENIB TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED] 4 Current NDC, 5 package rows 20241103_b5305e23-7bc6-44d8-b177-930c47d1653a.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 Units Marketing start Sample Exclude flag Status 13668-682-12 13668068212 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12) 2023-04-12 No No Current 13668-682-30 13668068230 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30) 2023-04-12 No No Current 13668-682-60 13668068260 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60) 2023-04-12 No No Current 13668-682-74 13668068274 10 BLISTER PACK in 1 CARTON (13668-682-74) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2023-04-12 No No Current