Home NDC 76297-002 NDC 76297-002 - 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 76297-002
Package NDCs from labels 76297-002-02, 76297-002-12, 76297-002-22
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 Label Manufacturer Effective date Type Factor IX Complex Profilnine ® GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA 2026-04-01 PLASMA DERIVATIVE Alanine - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA 2025-08-21 PLASMA DERIVATIVE dextrose - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA 2025-05-27 PLASMA DERIVATIVE Alphanate - GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA GRIFOLS USA, LLC | Grifols Biologicals LLC | LABORATORIOS GRIFOLS SA 2025-05-22 PLASMA DERIVATIVE Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA 2023-12-13 PLASMA DERIVATIVE Koate - KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA KEDRION BIOPHARMA, INC. | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA 2023-12-12 PLASMA DERIVATIVE PROLASTIN-C - GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA GRIFOLS USA, LLC | GRIFOLS THERAPEUTICS LLC | LABORATORIOS GRIFOLS SA 2022-02-25 PLASMA DERIVATIVE
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76297-002-02 Profilnine 5 mL in 1 VIAL, GLASS SOLUTION 5 mL 1 mL in 1mL 33 76297-002-12 Profilnine 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 33 76297-002-12 Profilnine 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 33 76297-002-12 THROMBATE III 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 31 76297-002-02 Alphanate 5 mL in 1 VIAL, GLASS SOLUTION 5 mL 1 mL in 1mL 26 76297-002-02 Alphanate 5 mL in 1 VIAL, GLASS SOLUTION 5 mL 1 mL in 1mL 26 76297-002-12 Alphanate 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 26 76297-002-12 Alphanate 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 26 76297-002-12 Alphanate 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 26 76297-002-12 AlphaNine SD 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 25 76297-002-12 AlphaNine SD 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 25 76297-002-12 AlphaNine SD 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 25 76297-002-22 PROLASTIN-C 20 mL in 1 VIAL, SINGLE-DOSE SOLUTION 20 mL 1 mL in 1mL 25 76297-002-02 Koate 5 mL in 1 VIAL, GLASS SOLUTION 5 mL 1 mL in 1mL 23 76297-002-02 Koate 5 mL in 1 VIAL, GLASS SOLUTION 5 mL 1 mL in 1mL 23 76297-002-12 Koate 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 23 76297-002-02 Koate 5 mL in 1 VIAL, GLASS SOLUTION 5 mL 1 mL in 1mL 10 76297-002-02 Koate 5 mL in 1 VIAL, GLASS SOLUTION 5 mL 1 mL in 1mL 10 76297-002-12 Koate 10 mL in 1 VIAL, GLASS SOLUTION 10 mL 1 mL in 1mL 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76297-002 PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] 29 Unmatched 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.zip 76297-002 THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT THROMBATE III (ANTITHROMBIN III (HUMAN)) KIT [GRIFOLS USA, LLC] 29 Unmatched 20231222_b2a9f856-3ef7-8da4-920c-f738e4f1f7d7.zip 76297-002 ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC] 25 Unmatched 20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip 76297-002 PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [GRIFOLS USA, LLC] 25 Unmatched 20220308_91edab72-c889-470e-8315-1798b5548dca.zip 76297-002 ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] 24 Unmatched 20240123_3e99052d-4442-4283-8915-c9a796c77008.zip 76297-002 KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] 23 Unmatched 20231228_2f77d685-e382-b2e7-2414-0d3a3448688a.zip 76297-002 KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.] 10 Unmatched 20231228_865df1e2-b4d1-dbf5-2899-a9c02df4d122.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 Alpha-1-proteinase Inhibitor Human ACTIVE INGREDIENT F43I396OIS PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC] 13 Alpha-1-proteinase Inhibitor Human ACTIVE MOIETY F43I396OIS PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC] 13 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC] 13 Sodium Phosphate INACTIVE INGREDIENT SE337SVY37 PROLASTIN-C (ALPHA-1-PROTEINASE INHIBITOR HUMAN) KIT [GRIFOLS USA, LLC] 13 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 Antihemophilic Factor Human ACTIVE INGREDIENT 839MOZ74GK KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Antithrombin Iii Human ACTIVE INGREDIENT T0LTO7L82X THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC] 11 Antihemophilic Factor Human ACTIVE MOIETY 839MOZ74GK KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Antithrombin Iii Human ACTIVE MOIETY T0LTO7L82X THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC] 11 Albumin (human) INACTIVE INGREDIENT ZIF514RVZR KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Aluminum INACTIVE INGREDIENT CPD4NFA903 KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Calcium Chloride INACTIVE INGREDIENT M4I0D6VV5M KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Glycine INACTIVE INGREDIENT TE7660XO1C KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Histidine INACTIVE INGREDIENT 4QD397987E KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 Tri-n-butyl Phosphate INACTIVE INGREDIENT 95UAS8YAF5 KOATE -DVI (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC] 11 COAGULATION FACTOR IX HUMAN ACTIVE INGREDIENT 6U90Y1795T ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] 10 Coagulation Factor IX Human ACTIVE MOIETY 6U90Y1795T ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] 10 dextrose INACTIVE INGREDIENT IY9XDZ35W2 ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] 10 heparin INACTIVE INGREDIENT T2410KM04A ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] 10 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] 10 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC] 10