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
Label	Manufacturer	Effective date	Type
Xyntha	Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC \| Wyeth Farma SA \| Pfizer Ireland Pharmaceuticals Unlimited Company	2026-03-16	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58394-124-03	Xyntha	4 mL in 1 SYRINGE	INJECTION, POWDER, LYOPHILIZED,	4 mL	1000 [iU] in 4mL	35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58394-124	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]	34	Unmatched	20250119_25ea1c3c-14a2-ef11-302e-012bd683924f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETED	ACTIVE INGREDIENT	113E3Z3CJJ	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETED	ACTIVE MOIETY	113E3Z3CJJ	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
SUCROSE	INACTIVE INGREDIENT	C151H8M554	XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	19
WATER	INACTIVE INGREDIENT	059QF0KO0R	XYNTHA (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 25 of 91 · 1,811 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dyural 40 Kit	METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL	Asclemed USA, Inc.	151ae26c-bd4e-4582-b67a-7b5baf466953	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
Dexlido Kit	DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE	Asclemed USA, Inc.	65428186-5fbb-4e1a-ae60-8824f3d62179	2026-01-08	Warnings, Adverse reactions	Exact identifier rxcui: 797544
Dexlido-M Kit	DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, MARICAINE, POVIDINE IODINE	Asclemed USA, Inc.	d3fd1d51-7749-4e1e-a8b5-8a151392f66d	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
DoubleDex Kit	DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE	Asclemed USA, Inc.	b7d58d9b-e1fa-4a7f-afca-beb06d028057	2026-01-08	Warnings, Adverse reactions	Exact identifier rxcui: 797544
Mardex 25 Kit	DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE	Asclemed USA, Inc.	94472ddb-ae1d-4a11-a673-81254d562e6b	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
Marlido 25 Kit	LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE	Asclemed USA, Inc.	1fe460e7-208d-410e-84c5-cd63005cff47	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
Ketorocaine LM Kit	KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE	Asclemed USA, Inc.	35ffe071-8bc1-4c88-8c85-645847acf169	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
Marbeta L Kit	BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL	Asclemed USA, Inc.	9a6a3871-4e02-47f9-a20e-a256b3f3c498	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
Dyural 80 Kit	METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL	Asclemed USA, Inc.	e9f7f923-e7f9-4c52-b56d-914d800c1acf	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
Dyural L Kit	METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL	Asclemed USA, Inc.	4879f990-e879-47e1-99bc-b4bfcb32bcff	2026-01-08	Warnings, Adverse reactions	Exact identifier rxcui: 797544
Multi-Specialty Kit	DEPO-MEDROL, LIDOCAINE, ISOPROPYL ALCOHOL	Asclemed USA, Inc.	5f2768d1-90c4-4d73-902d-fc7a947da7a5	2026-01-08	Warnings, Adverse reactions	Exact identifier rxcui: 797544
Ketorocaine L Kit	KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE	Asclemed USA, Inc.	ee0d396c-5caa-4a1a-9865-1a742d9d8d68	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
Dyural LM Kit	METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL	Asclemed USA, Inc.	cdd72141-10b6-48c6-85be-5b1294c8539c	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 797544
Thompson Alcohol	ISOPROPYL ALCOHOL	Thompson	f539db3b-f309-6a60-e053-2a95a90a5a9b	2026-01-08	Warnings	Exact identifier rxcui: 797544 unii: ND2M416302
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	NDC, Inc.	07bfadf4-7452-4c7a-b60e-feb658b92e73	2026-01-08	Warnings	Exact identifier unii: ND2M416302
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	McKesson Medical-Surgical Inc.	57ac1673-0652-433b-8b79-962d14e5b317	2026-01-08	Warnings	Exact identifier unii: ND2M416302
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	Henry Schein Inc.	eeaf255e-497b-4672-bebc-4d3fcba904c7	2026-01-08	Warnings	Exact identifier unii: ND2M416302
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	7-Eleven, Inc.	96d0488b-decd-4ffc-9179-29905a436bb1	2026-01-08	Warnings	Exact identifier unii: ND2M416302
Handy Solutions Rubbing Alcohol	ISOPROPYL ALCOHOL	Navajo Manufacturing Company Inc.	86268942-5526-47f6-b130-1b260d5a2403	2026-01-08	Warnings	Exact identifier unii: ND2M416302
Plus Rinse Emergency Eyewash	PURIFIED WATER	INNOVATIVE SAFETY SUPPLY INC.	b3f47d26-39e4-4aea-bb92-358def52b652	2026-01-08	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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