FDA.reportPublic FDA data

NDC 58394-124 - Xyntha

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
58394-124
Package NDCs from labels
58394-124-03
Manufacturer
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Wyeth Farma SA | Pfizer Ireland Pharmaceuticals Unlimited Company
Effective date
2026-03-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XynthaWyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Wyeth Farma SA | Pfizer Ireland Pharmaceuticals Unlimited Company2026-03-16PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58394-124-03Xyntha4 mL in 1 SYRINGEINJECTION, POWDER, LYOPHILIZED,4 mL1000 [iU] in 4mL35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58394-124XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]34Unmatched20250119_25ea1c3c-14a2-ef11-302e-012bd683924f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETEDACTIVE INGREDIENT113E3Z3CJJXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETEDACTIVE MOIETY113E3Z3CJJXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
HISTIDINEINACTIVE INGREDIENT4QD397987EXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
SUCROSEINACTIVE INGREDIENTC151H8M554XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
WATERINACTIVE INGREDIENT059QF0KO0RXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19

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 63 of 91 · 1,811 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Med-Nap Sterile Alcohol Prep PadsISOPROPYL ALCOHOLAcme United Corporationc6eff57b-d537-69c8-e053-2a95a90adc3a2024-11-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
First Aid Only Alcohol AntisepticISOPROPYL ALCOHOLAcme United Corporationa810e723-ad0c-8c71-e053-2995a90a0acc2024-11-23WarningsExact identifier
unii: ND2M416302
Universal 50% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC0dcc9bd2-aea5-4c27-9956-47d56221726b2024-11-22WarningsExact identifier
unii: ND2M416302
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC9a9d42ad-79d5-4acc-b5d9-cb7468961d472024-11-22WarningsExact identifier
unii: ND2M416302
Universal 50% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC044a6287-f568-4cfa-a813-7fc0e6ffc3522024-11-22WarningsExact identifier
unii: ND2M416302
NEXXGEN 70% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCce73ac48-c5af-4a35-950c-62ff0232aa302024-11-22WarningsExact identifier
unii: ND2M416302
Universal 70% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLCd8b9b0e7-2cb8-4fc5-af55-790e64d6cfe82024-11-22WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMazza Healthcare, LLCee83ba9f-ac65-48b7-9f84-5be6fec9a9092024-11-21WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol sterileISOPROPYL ALCOHOLCardinal Health, Incbb7c530f-5d80-4158-b715-09c1c837299d2024-11-21WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1936c5f4-274b-8e49-e063-6394a90ac6422024-11-21WarningsExact identifier
unii: ND2M416302
Alcohol sterileISOPROPYL ALCOHOLCardinal Health 200 LLC10135db9-f614-4511-96ac-faa6a02a1b612024-11-21WarningsExact identifier
rxcui: 797544
unii: ND2M416302
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd37f10b1f-b73c-4d71-91c2-1252f3d9d4ce2024-11-21WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1936c292-79c9-448a-e063-6294a90a11002024-11-21WarningsExact identifier
rxcui: 797544
unii: ND2M416302
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd11390854-9e72-40a2-9c89-3c29a585dced2024-11-21WarningsExact identifier
rxcui: 797544
unii: ND2M416302
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation37063a49-6b45-4167-875d-49c9dac3f79b2024-11-20WarningsExact identifier
unii: 451W47IQ8X
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporation6bb9a782-2394-4c8c-e053-2991aa0a08d42024-11-19WarningsExact identifier
unii: ND2M416302
First Aid Only Hand Sanitizing WipesISOPRPOYL ALCOHOLAcme United Corporationf54e7c1e-f7a0-d92e-e053-2a95a90ad05a2024-11-19WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
unii: ND2M416302
70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLC26cbc1af-a38f-146b-e063-6394a90a716c2024-11-13WarningsExact identifier
unii: ND2M416302
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Company99a15716-bbb9-4e33-a48d-20c58b81f3922024-11-13Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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