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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 36 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Citrate w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltdc9d0e9c8-379f-4895-b272-329efab575c42025-01-24Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Glucose and Sodium ChlorideDEXTROSE ANHYDROUS AND SODIUM CHLORIDEBaxter Healthcare Corporation1ba918d0-13d0-48bc-8742-658fc0eb47b62025-01-24Exact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation93aeac13-41de-4452-9f38-d6b4f38ada302025-01-24Exact identifier
unii: 451W47IQ8X
Bestmade Natural Products BM30ARG NITD3, ATROPIN SULPHD6, BUFO RAND10, CUPRUM ACETICD3, OENANTHE CROCD5, ZINC VALERIAND2Bestmade Natural Productsef0668d6-9c57-8b3e-e053-2995a90a6ba42025-01-23WarningsExact identifier
unii: J41CSQ7QDS
Bestmade Natural Products BM33ACID FOLICD10, ACID PHOSD4, ARSENIC ALBD4, AVENA SATD3, BETA VULGD5, CHINA OFFD12, FERR METD5, NATRUM MURD5Bestmade Natural Productsef2beaff-5c94-de60-e053-2995a90ad7962025-01-23WarningsExact identifier
unii: 451W47IQ8X
Sodium Citrate 4% w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd0775912f-f14a-4967-ac00-c8c1b36040bf2025-01-23Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Bestmade Natural Products Nat Mur (Lactose-Free)NATRUM MURIATICUMBestmade Natural Products2c4b8827-e724-858a-e063-6394a90a3b4e2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Productse9fb280b-2f79-f268-e053-2995a90a732c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio2KALI PHOS, MAG PHOS, NAT MUR, NAT SULFBestmade Natural Productse9fc4f2f-a699-163f-e053-2995a90ab1fe2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Productsea22e5e7-491a-91ac-e053-2a95a90a44142025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Productsea233792-038f-39e7-e053-2995a90a20ad2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio11FERR PHOS, KALI MUR, KALI SULF, NAT MUR, NAT SULFBestmade Natural Productseaa202d7-4297-57ba-e053-2995a90a02952025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Productseab251db-c69a-572d-e053-2a95a90ab3a02025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio13CALC PHOS, KALI SULF, KALI PHOS, NAT MURBestmade Natural Productseab2e339-c9e9-3048-e053-2995a90ae1492025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Productseac26053-7c65-7c56-e053-2995a90a8e642025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFBestmade Natural Productseb3b0d9d-5f1c-8a3b-e053-2a95a90a0e1f2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio27MAG PHOS, CALC PHOS, KALI PHOS, CALC FLUORBestmade Natural Productseb420652-ec68-6b46-e053-2995a90af98c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.61111d6e-2480-4e89-bb0e-d712f044bdc72025-01-20WarningsExact identifier
unii: 451W47IQ8X
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.