NDC 50419-310-01 - Vasovist

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: 50419-310
Requested NDC: 50419-310-01
Package NDCs from labels: 50419-310-01, 50419-310-02
Manufacturer: Bayer Healthcare, Inc.
Effective date: 2009-01-02
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Vasovist - Bayer Healthcare, Inc.	Bayer Healthcare, Inc.	2009-01-02	HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50419-310-01	Vasovist	10 mL in 1 VIAL, GLASS	INJECTION	10	1
50419-310-01	Vasovist	10 in 1 CARTON	INJECTION	10	1
50419-310-02	Vasovist	15 mL in 1 VIAL, GLASS	INJECTION	15	1
50419-310-02	Vasovist	10 in 1 CARTON	INJECTION	10	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-310	VASOVIST (GADOFOSVESET TRISODIUM) INJECTION [BAYER HEALTHCARE, INC.]	1	4 package rows	20090109_B6C35A62-A7EA-4C1D-A00A-24D82CDC65BE.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
gadofosveset trisodium	ACTIVE INGREDIENT	XM33Q67UVH	VASOVIST (GADOFOSVESET TRISODIUM) INJECTION [BAYER HEALTHCARE, INC.]	1
gadofosveset	ACTIVE MOIETY	E65RW73PHS	VASOVIST (GADOFOSVESET TRISODIUM) INJECTION [BAYER HEALTHCARE, INC.]	1
fosveset	INACTIVE INGREDIENT		VASOVIST (GADOFOSVESET TRISODIUM) INJECTION [BAYER HEALTHCARE, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	VASOVIST (GADOFOSVESET TRISODIUM) INJECTION [BAYER HEALTHCARE, INC.]	1

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4005F92E-1AC6-1CE7-EDA0-1A3FDF04CB7E			B6C35A62-A7EA-4C1D-A00A-24D82CDC65BE	2009-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 4005F92E-1AC6-1CE7-EDA0-1A3FDF04CB7E spl set id: B6C35A62-A7EA-4C1D-A00A-24D82CDC65BE

Reported adverse events (FAERS/openFDA)#

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