FDA.reportPublic FDA data

NDC 82950-112 - OJEMDA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
82950-112
Package NDCs from labels
82950-112-10
Manufacturer
Day One Biopharmaceuticals, Inc. | Shangzhou SynTheAll Pharmaceuticals Co. Ltda (STA) | Quotient Sciences - Philadelphia LLC | Sharp Packaging Services, LLC | PPD, L.P.
Effective date
2025-09-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OJEMDADay One Biopharmaceuticals, Inc. | Shangzhou SynTheAll Pharmaceuticals Co. Ltda (STA) | Quotient Sciences - Philadelphia LLC | Sharp Packaging Services, LLC | PPD, L.P.2025-09-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82950-112-10OJEMDA12 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION12 mL25 mg in 1mL9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82950-112OJEMDA (TOVORAFENIB) KIT OJEMDA (TOVORAFENIB) TABLET, FILM COATED [DAY ONE BIOPHARMACEUTICALS, INC.]8Unmatched20250515_ea3a9631-3a66-6a7c-e053-2995a90ae2ad.zip