FDA.reportPublic FDA data

NDC 0944-4138 - ADYNOVATE

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
0944-4138
Package NDCs from labels
0944-4138-01
Manufacturer
Takeda Pharmaceuticals Amercia, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH
Effective date
2025-10-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ADYNOVATE - Takeda Pharmaceuticals Amercia, Inc. | BAXALTA US INC. | Siegfried Hameln GmbHTakeda Pharmaceuticals Amercia, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH2025-10-16PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-4138-01ADYNOVATE5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL500 [iU] in 2mL23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-4138ADYNOVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED) KIT [TAKEDA PHARMACEUTICALS AMERCIA, INC.]22Unmatched20250331_ef290433-997f-4e98-86d6-42f6a99d6d18.zip