Home NDC 82950-001 OJEMDA
Product NDC 82950-001
11-digit product format 829500001
Labeler code 82950
Product ID 82950-001_8bee41f8-a2d9-44ae-82a9-bd46b6f9916a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOVORAFENIB
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Day One Biopharmaceuticals, Inc.
Application NDA217700
Marketing category NDA
Marketing start 2024-04-30
Substance TOVORAFENIB
Active strength 100 mg/1
Pharmacologic classes Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Type II RAF 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 43 .
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 N217700-001 OJEMDA TOVORAFENIB 100MG TABLET / ORAL RLD, RS 2024-04-23
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 N217700-001 10426782 2035-06-23 Drug product 2024-05-08
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217700-001 NCE 2029-04-23 N217700-001 ODE-478 2031-04-23
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 2026-09-14 22:38:34 2026-08 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217700-001 OJEMDA 100MG TABLET / ORAL RLD, RS 2024-04-23 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217700-001 8293752 2031-08-04 Drug substance, Drug product 2024-05-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217700-001 10426782 2035-06-23 Drug product 2024-05-08 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base OJEMDA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOVORAFENIB 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZN90E4027M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2682439 Internal RxNorm lookup 2682445 Internal RxNorm lookup 2682450 Internal RxNorm lookup 2682454 Internal RxNorm lookup 2690857 Internal RxNorm lookup 2690858 Internal RxNorm lookup 2690859 Internal RxNorm lookup 2690860 Internal RxNorm lookup 2690861 Internal RxNorm lookup 2690862 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 82950-001-04 OJEMDA 4 in 1 BLISTER PACK TABLET, FILM COATED 4 9 82950-001-05 OJEMDA 5 in 1 BLISTER PACK TABLET, FILM COATED 5 9 82950-001-06 OJEMDA 6 in 1 BLISTER PACK TABLET, FILM COATED 6 9 82950-001-16 OJEMDA 4 in 1 CARTON TABLET, FILM COATED 4 9 82950-001-20 OJEMDA 4 in 1 CARTON TABLET, FILM COATED 4 9 82950-001-24 OJEMDA 4 in 1 CARTON TABLET, FILM COATED 4 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82950-001 OJEMDA (TOVORAFENIB) KIT OJEMDA (TOVORAFENIB) TABLET, FILM COATED [DAY ONE BIOPHARMACEUTICALS, INC.] 8 Current NDC, 6 package rows 20250515_ea3a9631-3a66-6a7c-e053-2995a90ae2ad.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 OJEMDA TOVORAFENIB Day One Biopharmaceuticals, Inc. ea3a9631-3a66-6a7c-e053-2995a90ae2ad 2025-09-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 217700 application number: NDA217700 ndc (product): 82950-001
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2690858 {16 (tovorafenib 100 MG Oral Tablet [Ojemda]) } Pack [Ojemda 400 MG Once Weekly Carton] BPCK ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690860 {20 (tovorafenib 100 MG Oral Tablet [Ojemda]) } Pack [Ojemda 500 MG Once Weekly Carton] BPCK ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690862 {24 (tovorafenib 100 MG Oral Tablet [Ojemda]) } Pack [Ojemda 600 MG Once Weekly Carton] BPCK ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690857 {16 (tovorafenib 100 MG Oral Tablet) } Pack GPCK ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690859 {20 (tovorafenib 100 MG Oral Tablet) } Pack GPCK ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690861 {24 (tovorafenib 100 MG Oral Tablet) } Pack GPCK ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682454 ojemda 100 MG Oral Tablet PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682445 ojemda 25 MG in 1 mL Powder for Oral Suspension PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690858 ojemda 400 MG Weekly Dose Carton Pack PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690860 ojemda 500 MG Weekly Dose Carton Pack PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690862 ojemda 600 MG Weekly Dose Carton Pack PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682450 tovorafenib 100 MG Oral Tablet PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682439 tovorafenib 25 MG in 1 mL Powder for Oral Suspension PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690857 tovorafenib 400 MG Weekly Dose Carton Pack, 100 MG Oral Tablet 16 Count Pack PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690859 tovorafenib 500 MG Weekly Dose Carton Pack, 100 MG Oral Tablet 20 Count Pack PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690861 tovorafenib 600 MG Weekly Dose Carton Pack, 100 MG Oral Tablet 24 Count Pack PSN ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682454 tovorafenib 100 MG Oral Tablet [Ojemda] SBD ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682445 tovorafenib 300 MG Powder for Oral Suspension [Ojemda] SBD ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682450 tovorafenib 100 MG Oral Tablet SCD ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682439 tovorafenib 300 MG Powder for Oral Suspension SCD ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682454 Ojemda 100 MG Oral Tablet SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682445 Ojemda 25 MG per 1 ML Powder for Oral Suspension SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682445 Ojemda 300 MG per 12 ML Powder for Oral Suspension SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682445 Ojemda 300 MG Powder for Oral Suspension SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690858 Ojemda 400 MG Weekly Dose Carton Pack, 4 Blister Cards, 4 Tablets Each SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690860 Ojemda 500 MG Weekly Dose Carton Pack, 5 Blister Cards, 4 Tablets Each SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690862 Ojemda 600 MG Weekly Dose Carton Pack, 4 Blister Cards, 6 Tablets Each SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682450 tovorafenib 100 MG Oral Tablet SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682439 tovorafenib 25 MG per 1 ML Powder for Oral Suspension SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2682439 tovorafenib 300 MG per 12 ML Powder for Oral Suspension SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690857 tovorafenib 400 MG Weekly Dose Carton Pack, 4 Blister Cards, 4 Tablets Each SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690859 tovorafenib 500 MG Weekly Dose Carton Pack, 5 Blister Cards, 4 Tablets Each SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9 2690861 tovorafenib 600 MG Weekly Dose Carton Pack, 4 Blister Cards, 6 Tablets Each SY ea3a9631-3a66-6a7c-e053-2995a90ae2ad 9
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82950-001-04 82950000104 4 in 1 BLISTER PACK Historical 82950-001-05 82950000105 5 in 1 BLISTER PACK Historical 82950-001-06 82950000106 6 in 1 BLISTER PACK Historical 82950-001-16 82950000116 4 BLISTER PACK in 1 CARTON (82950-001-16) / 4 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-04) 4 blister pack 2024-04-30 No No Current 82950-001-20 82950000120 4 BLISTER PACK in 1 CARTON (82950-001-20) / 5 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-05) 4 blister pack 2025-04-30 No No Current 82950-001-24 82950000124 4 BLISTER PACK in 1 CARTON (82950-001-24) / 6 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-06) 4 blister pack 2024-04-30 No No Current