FDA.reportPublic FDA data

NDC 68516-3206 - Profilnine

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
68516-3206
Package NDCs from labels
68516-3206-2
Manufacturer
GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA
Effective date
2026-04-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Factor IX Complex Profilnine ®GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA2026-04-01PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68516-3206-2Profilnine10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mL1500 [iU] in 10mL33
68516-3206-2Profilnine10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mL1500 [iU] in 10mL33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68516-3206PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]29Unmatched20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
factor ix complexACTIVE INGREDIENTFW411QXD5MPROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15
factor ix complexACTIVE MOIETYFW411QXD5MPROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRPROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15
sodium phosphateINACTIVE INGREDIENTSE337SVY37PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]15