Tegsedi

Manufacturer: Catalent Indiana, LLC
Effective date: 2025-08-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:02:58

Label at a glance#

ProductTegsedi

Active ingredientINOTERSEN SODIUM

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

139-105-300 EXP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2099318	inotersen 284 MG in 1.5 mL Prefilled Syringe	PSN	1
2099323	Tegsedi 284 MG in 1.5 mL Prefilled Syringe	PSN	1
2099323	1.5 ML inotersen 189 MG/ML Prefilled Syringe [Tegsedi]	SBD	1
2099318	1.5 ML inotersen 189 MG/ML Prefilled Syringe	SCD	1
2099318	inotersen 189 MG/ML per 1.5 ML Prefilled Syringe	SY	1
2099318	inotersen 284 MG per 1.5 ML Prefilled Syringe	SY	1
2099323	Tegsedi 189 MG/ML per 1.5 ML Prefilled Syringe	SY	1
2099323	Tegsedi 284 MG per 1.5 ML Prefilled Syringe	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
INOTERSEN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20190712

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	XXXMYYZ		139-105-300 LBL EXP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
43c6b594-9c47-4766-81ae-e9e67b80b614	Product name	1	20190108

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Tegsedi
Inotersen
INOTERSEN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61434-031	61434-031-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
INOTERSEN SODIUM	950736UC77	ACTIM

Source Document#

Source XML

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.