NDC 61434-031 - Tegsedi

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: 61434-031
Package NDCs from labels: 61434-031-03
Manufacturer: Catalent Indiana, LLC
Effective date: 2025-08-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Tegsedi - Catalent Indiana, LLC	Catalent Indiana, LLC	2025-08-13	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61434-031-03	Tegsedi	1.5 mL in 1 SYRINGE	INJECTION, SOLUTION	1.5		1
61434-031-03	Tegsedi	800 in 1 CASE	INJECTION, SOLUTION	800		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
3d31f4e1-431f-d3f2-e063-6394a90a6723			3d31f4c0-35bb-c990-e063-6394a90a749f	2025-08-13		Exact identifier spl id: 3d31f4e1-431f-d3f2-e063-6394a90a6723 spl set id: 3d31f4c0-35bb-c990-e063-6394a90a749f

Reported adverse events (FAERS/openFDA)#

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