FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
OJEMDA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOVORAFENIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZN90E4027M
Rxcui2682439, 2682445, 2682450, 2682454, 2690857, 2690858, 2690859, 2690860, 2690861, 2690862

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9b7e90a1-dd9a-4025-8f33-293403950c20Product name120250211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82950-001-04OJEMDA4 in 1 BLISTER PACKTABLET, FILM COATED49
82950-001-05OJEMDA5 in 1 BLISTER PACKTABLET, FILM COATED59
82950-001-06OJEMDA6 in 1 BLISTER PACKTABLET, FILM COATED69
82950-001-16OJEMDA4 in 1 CARTONTABLET, FILM COATED49
82950-001-20OJEMDA4 in 1 CARTONTABLET, FILM COATED49
82950-001-24OJEMDA4 in 1 CARTONTABLET, FILM COATED49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82950-001-16EA - Each82950-00150fab423-d740-4d12-b996-dcaade01e18c12024-05-16
82950-001-20EA - Each82950-00108bb987a-1876-4303-a92e-09a004f95dc412024-05-16
82950-001-24EA - Each82950-001a6b37be4-b2d9-4f5e-a0ee-cbd63c01262c12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82950-001OJEMDA (TOVORAFENIB) KIT OJEMDA (TOVORAFENIB) TABLET, FILM COATED [DAY ONE BIOPHARMACEUTICALS, INC.]8Current NDC, 6 package rows20250515_ea3a9631-3a66-6a7c-e053-2995a90ae2ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2690858{16 (tovorafenib 100 MG Oral Tablet [Ojemda]) } Pack [Ojemda 400 MG Once Weekly Carton]BPCKea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690860{20 (tovorafenib 100 MG Oral Tablet [Ojemda]) } Pack [Ojemda 500 MG Once Weekly Carton]BPCKea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690862{24 (tovorafenib 100 MG Oral Tablet [Ojemda]) } Pack [Ojemda 600 MG Once Weekly Carton]BPCKea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690857{16 (tovorafenib 100 MG Oral Tablet) } PackGPCKea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690859{20 (tovorafenib 100 MG Oral Tablet) } PackGPCKea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690861{24 (tovorafenib 100 MG Oral Tablet) } PackGPCKea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682454ojemda 100 MG Oral TabletPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682445ojemda 25 MG in 1 mL Powder for Oral SuspensionPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690858ojemda 400 MG Weekly Dose Carton PackPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690860ojemda 500 MG Weekly Dose Carton PackPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690862ojemda 600 MG Weekly Dose Carton PackPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682450tovorafenib 100 MG Oral TabletPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682439tovorafenib 25 MG in 1 mL Powder for Oral SuspensionPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690857tovorafenib 400 MG Weekly Dose Carton Pack, 100 MG Oral Tablet 16 Count PackPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690859tovorafenib 500 MG Weekly Dose Carton Pack, 100 MG Oral Tablet 20 Count PackPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690861tovorafenib 600 MG Weekly Dose Carton Pack, 100 MG Oral Tablet 24 Count PackPSNea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682454tovorafenib 100 MG Oral Tablet [Ojemda]SBDea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682445tovorafenib 300 MG Powder for Oral Suspension [Ojemda]SBDea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682450tovorafenib 100 MG Oral TabletSCDea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682439tovorafenib 300 MG Powder for Oral SuspensionSCDea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682454Ojemda 100 MG Oral TabletSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682445Ojemda 25 MG per 1 ML Powder for Oral SuspensionSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682445Ojemda 300 MG per 12 ML Powder for Oral SuspensionSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682445Ojemda 300 MG Powder for Oral SuspensionSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690858Ojemda 400 MG Weekly Dose Carton Pack, 4 Blister Cards, 4 Tablets EachSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690860Ojemda 500 MG Weekly Dose Carton Pack, 5 Blister Cards, 4 Tablets EachSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690862Ojemda 600 MG Weekly Dose Carton Pack, 4 Blister Cards, 6 Tablets EachSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682450tovorafenib 100 MG Oral TabletSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682439tovorafenib 25 MG per 1 ML Powder for Oral SuspensionSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2682439tovorafenib 300 MG per 12 ML Powder for Oral SuspensionSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690857tovorafenib 400 MG Weekly Dose Carton Pack, 4 Blister Cards, 4 Tablets EachSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690859tovorafenib 500 MG Weekly Dose Carton Pack, 5 Blister Cards, 4 Tablets EachSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9
2690861tovorafenib 600 MG Weekly Dose Carton Pack, 4 Blister Cards, 6 Tablets EachSYea3a9631-3a66-6a7c-e053-2995a90ae2ad9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82950-001-04829500001044 in 1 BLISTER PACKHistorical
82950-001-05829500001055 in 1 BLISTER PACKHistorical
82950-001-06829500001066 in 1 BLISTER PACKHistorical
82950-001-16829500001164 BLISTER PACK in 1 CARTON (82950-001-16) / 4 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-04) 4 blister pack2024-04-30NoNoHistorical
82950-001-20829500001204 BLISTER PACK in 1 CARTON (82950-001-20) / 5 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-05) 4 blister pack2025-04-30NoNoHistorical
82950-001-24829500001244 BLISTER PACK in 1 CARTON (82950-001-24) / 6 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-06) 4 blister pack2024-04-30NoNoHistorical