FDA.reportPublic FDA data

NDC 0944-3029 - RIXUBIS

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
0944-3029
Package NDCs from labels
0944-3029-01
Manufacturer
Takeda Pharmaceuticals America, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH | Takeda Manufacturing Austria AG | Takeda Manufacturing Singapore Pte. Ltd. | OFI Technologie & Innovation GmbH
Effective date
2026-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RIXUBISTakeda Pharmaceuticals America, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH | Takeda Manufacturing Austria AG | Takeda Manufacturing Singapore Pte. Ltd. | OFI Technologie & Innovation GmbH2026-05-12PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-3029-01RIXUBIS5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL1000 [iU] in 5mL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-3029RIXUBIS (COAGULATION FACTOR IX (RECOMBINANT)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]13Unmatched20250410_f5070a92-96b8-476a-a2dc-18b22d95e5e0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAGULATION FACTOR IX RECOMBINANT HUMANACTIVE INGREDIENT382L14738LRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
COAGULATION FACTOR IX RECOMBINANT HUMANACTIVE MOIETY382L14738LRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
HISTIDINEINACTIVE INGREDIENT4QD397987ERIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ARIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2
SUCROSEINACTIVE INGREDIENTC151H8M554RIXUBIS (COAGULATION FACTOR IX RECOMBINANT HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]2

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 56 of 56 · 1,107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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