FDA.reportPublic FDA data

NDC 64208-7754 - Coagadex

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
64208-7754
Package NDCs from labels
64208-7754-1
Manufacturer
Bio Products Laboratory Ltd
Effective date
2026-04-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Coagadex - Bio Products Laboratory LtdBio Products Laboratory Ltd2026-04-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64208-7754-1Coagadex10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,10 mL100 [iU] in 1mL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64208-7754COAGADEX (COAGULATION FACTOR X HUMAN) KIT [BIO PRODUCTS LABORATORY LIMITED]12Unmatched20241101_ad20e6ff-98bc-47e6-aa00-7fb441edd2b0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Coagulation Factor X HumanACTIVE INGREDIENT0P94UQE6SYCOAGADEX (COAGULATION FACTOR X HUMAN) KIT [BIO PRODUCTS LABORATORY LIMITED]3
Coagulation Factor X HumanACTIVE MOIETY0P94UQE6SYCOAGADEX (COAGULATION FACTOR X HUMAN) KIT [BIO PRODUCTS LABORATORY LIMITED]3
WaterINACTIVE INGREDIENT059QF0KO0RCOAGADEX (COAGULATION FACTOR X HUMAN) KIT [BIO PRODUCTS LABORATORY LIMITED]3