FDA.reportPublic FDA data

NDC 13533-605 - THROMBATE III

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
13533-605
Package NDCs from labels
13533-605-21
Manufacturer
GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA
Effective date
2025-08-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alanine - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SAGRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA2025-08-21PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13533-605-21THROMBATE III10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL50 [iU] in 1mL31
13533-605-21THROMBATE III10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL50 [iU] in 1mL31
13533-605-21THROMBATE III10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL50 [iU] in 1mL31
13533-605-21THROMBATE III10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL50 [iU] in 1mL31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13533-605THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC]29Unmatched20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Antithrombin Iii HumanACTIVE INGREDIENTT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11
Antithrombin Iii HumanACTIVE MOIETYT0LTO7L82XTHROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]11