FDA.reportPublic FDA data

NDC 64764-519 - FEIBA

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
64764-519
Package NDCs from labels
64764-519-50
Manufacturer
Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH
Effective date
2025-11-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FEIBA - Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbHTakeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH2025-11-27HUMAN PRESCRIPTION DRUG LABEL
Aralast NP - Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbHTakeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH2025-11-25PLASMA DERIVATIVE

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-519FEIBA (ANTI-INHIBITOR COAGULANT COMPLEX) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]29Unmatched20250109_752604e5-4ea2-44f4-83ed-1569373f6412.zip
64764-519ARALAST NP (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]18Unmatched20241121_a9a5b46e-04da-41bd-bb5f-c4936b664fef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTI-INHIBITOR COAGULANT COMPLEXACTIVE INGREDIENTCS849DUN3MFEIBA NF (ANTI-INHIBITOR COAGULANT COMPLEX) KIT [BAXTER HEALTHCARE CORPORATION]7
ANTI-INHIBITOR COAGULANT COMPLEXACTIVE MOIETYCS849DUN3MFEIBA NF (ANTI-INHIBITOR COAGULANT COMPLEX) KIT [BAXTER HEALTHCARE CORPORATION]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFEIBA NF (ANTI-INHIBITOR COAGULANT COMPLEX) KIT [BAXTER HEALTHCARE CORPORATION]7
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KFEIBA NF (ANTI-INHIBITOR COAGULANT COMPLEX) KIT [BAXTER HEALTHCARE CORPORATION]7
WaterINACTIVE INGREDIENT059QF0KO0RFEIBA NF (ANTI-INHIBITOR COAGULANT COMPLEX) KIT [BAXTER HEALTHCARE CORPORATION]7
.ALPHA.1-PROTEINASE INHIBITOR HUMANACTIVE INGREDIENTF43I396OISARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
.ALPHA.1-PROTEINASE INHIBITOR HUMANACTIVE MOIETYF43I396OISARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
TRI-N-BUTYL PHOSPHATEINACTIVE INGREDIENT95UAS8YAF5ARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
ZINCINACTIVE INGREDIENTJ41CSQ7QDSARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4