FDA.reportPublic FDA data

NDC 68982-261-81 - Balfaxar

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
68982-261
Requested NDC
68982-261-81
Package NDCs from labels
68982-261-81, 68982-261-01, 68982-261-82, 68982-261-02
Manufacturer
Octapharma USA Inc
Effective date
2023-07-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Balfaxar - Octapharma USA IncOctapharma USA Inc2023-07-21PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68982-261-01Balfaxar1 in 1 CARTONPOWDER, FOR SOLUTION14
68982-261-02Balfaxar1 in 1 CARTONPOWDER, FOR SOLUTION14
68982-261-81Balfaxar20 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION204
68982-261-82Balfaxar40 mL in 1 VIAL, GLASSPOWDER, FOR SOLUTION404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-261BALFAXAR (PROTHROMBIN COMPLEX CONCENTRATE (HUMAN)) POWDER, FOR SOLUTION [OCTAPHARMA USA INC]4Current NDC, 4 package rows20231130_68fa4f90-8b01-6498-4140-e0be5247c3fe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-261-01EA - Each68982-261649b9bd0-168e-4005-a60d-a79893c31ec512023-09-05
68982-261-02EA - Each68982-26180c4103a-3634-4386-b099-afa9a0507da412023-09-05
68982-261-81EA - Each68982-26155b6b4a7-8d79-4556-9d25-1b568453373512023-09-05
68982-261-82EA - Each68982-261773ef64f-8f8b-41c2-96e1-eb04926dad4312023-09-05

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
CoagadexCOAGULATION FACTOR X HUMANBio Products Laboratory Ltdad20e6ff-98bc-47e6-aa00-7fb441edd2b02026-04-13Warnings, Adverse reactionsName fallback
generic name: COAGULATION FACTOR X HUMAN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.