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 20 of 91 · 1,811 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineISOPROPYL ALCOHOLHy-Vee, Inc.4bbce274-1e62-0c6a-e063-6394a90af92f2026-02-10WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Youmi Alcohol Prep Pad 70 Isopropyl AlcoholISOPROPYL ALCOHOLPT YOUMI MEDIKA INDUSTRIe3b1a576-a8eb-44bf-8f9c-a49a44a894e82026-02-09WarningsExact identifier
rxcui: 797544
unii: ND2M416302
EVERLIT CARE PRODUCTS PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.77a60360-8bb5-43e9-b7e4-f71d2d488c442026-02-09WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Everlit Care Products Sting ReliefISOPROPYL ALCOHOLEVERLIT GLOBAL INC.adfab206-b7de-4f6a-a864-edd946ea743d2026-02-09WarningsExact identifier
unii: ND2M416302
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Lifesciences Limited4bae0e2a-dd36-4987-85ee-36a52e642ec72026-02-09Warnings, Adverse reactionsExact identifier
rxcui: 797544
AlcoholISOPROPYL ALCOHOLA-S Medication Solutions6b8834be-0235-4f7c-8d52-c2f6aa2d30492026-02-08WarningsExact identifier
rxcui: 797544
unii: ND2M416302
70% RubbingISOPROPYL ALCOHOLWalgreens Co.6ad37d18-5c19-4b5f-8313-edd430f84fb02026-02-05Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWalgreens Co.1473e6e4-dc5f-43d9-a249-111a181e3f762026-02-05Warnings, Adverse reactionsExact identifier
unii: ND2M416302
ForPro Premium Sterile Antiseptic Isopropyl Alcohol PadsISOPROPYL ALCOHOLTng workdwide6cc2ccae-b288-473e-a736-0974c96dbb892026-02-05WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPharmacy Value Alliance, LLC528011d7-8c6d-4940-bee1-52b39acef40d2026-02-05Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPublix Super Markets, Inc.14aecc7b-c68a-4cb9-863f-475e204f66a52026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLPublix Super Markets, Inc.b3b5324b-ee2c-4f87-9bb9-81d3d85f73ee2026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 50 percentISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)b1b52183-3296-48b2-b3d3-821c141b0bea2026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 50 percentISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ee67fb96-fa2c-4542-8fdb-f2ccd885ee532026-02-05WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLDyad Medical Sourcing, LLCb5c9e222-10eb-4cea-af70-213a77fcc8652026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLGoBrands, Inc.0fb3db50-4132-07dc-e063-6294a90a81682026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLGrocery Outlet, Inc.3dff8c83-7c33-7bca-e063-6394a90a675f2026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLGrocery Outlet, Inc.3dffba95-71c4-a2b0-e063-6394a90aaeb32026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
91% ISOPROPYL ALCOHOL91% ISOPROPYL ALCOHOLHy-Vee, Inc.497471bb-541c-f945-e063-6294a90adbb22026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLHy-Vee, Inc.4831eecf-d111-6f17-e063-6394a90a4ab92026-02-04Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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