NDC 69911-877 - IDELVION

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
69911-877
Package NDCs from labels
69911-877-01
Manufacturer
CSL Behring Lengnau AG | CSL Behring GmbH | CSL Behring LLC
Effective date
2023-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IDELVION - CSL Behring Lengnau AG | CSL Behring GmbH | CSL Behring LLCCSL Behring Lengnau AG | CSL Behring GmbH | CSL Behring LLC2023-06-30PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69911-877-01IDELVION5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,5 mL2000 [iU] in 5mL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69911-877IDELVION (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [CSL BEHRING LENGNAU AG]12Unmatched20230706_f74301bf-95e2-44ab-a8b6-98aa07b04683.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 14 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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