FDA.reportPublic FDA data

NDC 68516-3604 - AlphaNine SD

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
68516-3604
Package NDCs from labels
68516-3604-2
Manufacturer
GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA
Effective date
2025-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
dextrose - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SAGRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA2025-05-27PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68516-3604-2AlphaNine SD10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mL500 [iU] in 10mL25
68516-3604-2AlphaNine SD10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mL500 [iU] in 10mL25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68516-3604ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]24Unmatched20240123_3e99052d-4442-4283-8915-c9a796c77008.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAGULATION FACTOR IX HUMANACTIVE INGREDIENT6U90Y1795TALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
Coagulation Factor IX HumanACTIVE MOIETY6U90Y1795TALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
dextroseINACTIVE INGREDIENTIY9XDZ35W2ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
heparinINACTIVE INGREDIENTT2410KM04AALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10