FDA.reportPublic FDA data

Xyntha

Product NDC
58394-014
11-digit product format
583940014
Labeler code
58394
Product ID
58394-014_5f2d1c61-a588-484c-b240-3bf0e6120713
Type
PLASMA DERIVATIVE
Nonproprietary name
antihemophilic factor (recombinant)
Dosage form
KIT
Labeler
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Application
BLA125264
Marketing category
BLA
Marketing start
2008-08-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xyntha
Listing expiration
2026-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58394-014-01Xyntha1 in 1 CARTONKIT133
58394-114-01Xyntha4 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,4 mL1000 [iU] in 4mL33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58394-014-01EA - Each58394-014187b7c95-c6d4-407f-936c-ab0c9372ff9c12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58394-014XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]33Current NDC, Legacy NDC, 2 package rows20250303_52e97c7f-8240-4cd6-afd2-c452ab2f6e32.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125264Xyntha, Xyntha SolofuseAntihemophilic Factor (Recombinant), Plasma/Albumin Free351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718993antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT InjectionPSN52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
797544isopropyl alcohol 70 % Medicated PadPSN52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
1718996Xyntha 1 UNT InjectionPSN52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
1718996antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Injection [Xyntha]SBD52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
1718993antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT InjectionSCD52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
1718993factor VIII, human recombinant residues 743-1636 deleted 1 UNT InjectionSY52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
797544isopropyl alcohol 70 % Medicated PadSY52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
797544isopropyl alcohol 70 % Topical ClothSY52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
797544isopropyl alcohol 70 % Topical SwabSY52e97c7f-8240-4cd6-afd2-c452ab2f6e3233
1718996Xyntha 1 UNT InjectionSY52e97c7f-8240-4cd6-afd2-c452ab2f6e3233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58394-014-01583940014011 KIT in 1 CARTON (58394-014-01) * 4 mL in 1 SYRINGE (58394-018-01) * 1 mL in 1 PACKET * 4 mL in 1 VIAL, SINGLE-USE (58394-114-01) 1 kit2008-08-010000-00-00NoNoCurrent
58394-114-01583940114014 mL in 1 VIAL, SINGLE-USE4 mlHistorical