Home NDC 68516-1001 NDC 68516-1001 - 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 68516-1001
Package NDCs from labels 68516-1001-1
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68516-1001-1 Profilnine 5 mL in 1 VIAL, SINGLE-DOSE INJECTION 5 mL 1 mL in 1mL 33 68516-1001-1 Alphanate 5 mL in 1 VIAL, SINGLE-DOSE INJECTION 5 mL 1 mL in 1mL 26 68516-1001-1 Alphanate 5 mL in 1 VIAL, SINGLE-DOSE INJECTION 5 mL 1 mL in 1mL 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68516-1001 PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] 29 Unmatched 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip 68516-1001 ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] 25 Unmatched 20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded factor ix complex ACTIVE INGREDIENT FW411QXD5M PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] 15 factor ix complex ACTIVE MOIETY FW411QXD5M PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] 15 sodium chloride INACTIVE INGREDIENT 451W47IQ8X PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] 15 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] 15 sodium phosphate INACTIVE INGREDIENT SE337SVY37 PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] 15 HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX ACTIVE INGREDIENT 5T6B772R4Q ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] 12 HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX ACTIVE MOIETY 5T6B772R4Q ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] 12 albumin (human) INACTIVE INGREDIENT ZIF514RVZR ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] 12 arginine INACTIVE INGREDIENT 94ZLA3W45F ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] 12 histidine INACTIVE INGREDIENT 4QD397987E ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] 12