FDA.reportPublic FDA data

NDC 58394-112 - 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
58394-112
Package NDCs from labels
58394-112-01
Manufacturer
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Wyeth Farma SA | Pfizer Ireland Pharmaceuticals Unlimited Company
Effective date
2025-02-27
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 Company2025-02-27PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58394-112-01Xyntha4 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,4 mL250 [iU] in 4mL33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58394-112XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]33Unmatched20250303_52e97c7f-8240-4cd6-afd2-c452ab2f6e32.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.]16
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]16
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.]16
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]16
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]16
HISTIDINEINACTIVE INGREDIENT4QD397987EXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]16
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]16
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]16
SUCROSEINACTIVE INGREDIENTC151H8M554XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]16
WATERINACTIVE INGREDIENT059QF0KO0RXYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]16

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 77 of 91 · 1,811 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
rxcui: 797544
unii: ND2M416302
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
unii: 451W47IQ8X
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c7f9a00-6600-4b0d-af11-fa776b22e6782023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c9f2c8b-6ed6-4e54-a151-5be4acb290e42023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd878bfaa7-d553-40db-8311-19010930abd92023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc1273e40-5c09-435b-adf3-e352fdd01e9e2023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Preps SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd65c8f4de-6516-4caa-a458-228b7b4f6f782023-10-23WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc13af96e-f76a-4577-8d57-811ccc6527382023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep Pad 70 Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltdaf84e47f-01d6-d24e-e053-2a95a90a7edd2023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep Pad Non-SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd9b835128-194a-4527-abd5-c507ca94b1972023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep Pad SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltda4d1f759-7f35-d277-e053-2a95a90abc8c2023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol SwabstickISOPROPYL ALCOHOLJianerkang Medical Co., Ltdb576911b-bbf2-4ce7-a94a-29bbf719f2052023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Swabsticks 1s SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltdf725587c-ed7b-48de-885a-ac464e72e6d22023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Swabsticks 3s SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd6b21e472-d473-4b22-bc31-78b00c523e2d2023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep Pad Medium PadISOPROPYL ALCOHOLHenry Schein Inc.bdd02ae1-782a-dc72-e053-2a95a90a75542023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep Pad Medium PadISOPROPYL ALCOHOLHenry Schein Inc.b46933ab-41f5-7513-e053-2a95a90a0c692023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Alcohol Prep Pad Large PadISOPROPYL ALCOHOLHenry Schein Inc.b468eefd-625b-5c27-e053-2995a90ab0f42023-10-23WarningsExact identifier
rxcui: 797544
unii: ND2M416302
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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