NDC 0338-7112 - TISSEEL Fibrin Sealant

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: 0338-7112
Package NDCs from labels: 0338-7112-01, 0338-7112-02, 0338-7112-05
Manufacturer: Baxter Healthcare Corporation
Effective date: 2025-09-30
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
TISSEEL Fibrin Sealant - Baxter Healthcare Corporation	Baxter Healthcare Corporation	2025-09-30	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-7112-01	TISSEELFibrin Sealant	1 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	1 mL	86.5 mg in 1mL	9
0338-7112-01	TISSEELFibrin Sealant	1 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	1 mL	86.5 mg in 1mL	9
0338-7112-02	TISSEELFibrin Sealant	2 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	2 mL	86.5 mg in 1mL	9
0338-7112-02	TISSEELFibrin Sealant	2 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	2 mL	86.5 mg in 1mL	9
0338-7112-05	TISSEELFibrin Sealant	5 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	5 mL	86.5 mg in 1mL	9
0338-7112-05	TISSEELFibrin Sealant	5 mL in 1 VIAL, GLASS	POWDER, FOR SOLUTION	5 mL	86.5 mg in 1mL	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-7112	TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) KIT TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) SOLUTION [BAXTER HEALTHCARE CORPORATION]	8	Unmatched	20240802_b3f69e25-1b87-4507-81fa-582ea084673d.zip

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 65 of 65 · 1,282 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13		Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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