FDA.reportPublic FDA data

NDC 68982-348 - Fibryga

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
68982-348
Package NDCs from labels
68982-348-01
Manufacturer
Octapharma USA Inc
Effective date
2024-07-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fibryga - Octapharma USA IncOctapharma USA Inc2024-07-31PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68982-348-01Fibryga50 mL in 1 BOTTLE, GLASSPOWDER, FOR SOLUTION50 mL20 mg in 1mL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-348FIBRYGA (FIBRINOGEN (HUMAN)) KIT [OCTAPHARMA USA INC]13Unmatched20240823_007a93f4-d84b-1fa9-51ed-32f6140bf423.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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TachoSilTHROMBIN HUMAN AND FIBRINOGENCorza Medical GmbH0c324332-290f-413f-820c-8c9a971a27662025-10-08Warnings, Adverse reactionsExact identifier
unii: N94833051K