TEGSEDI- inotersen injection, solution

Tegsedi by

Drug Labeling and Warnings

Tegsedi by is a Prescription medication manufactured, distributed, or labeled by Catalent Indiana, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEGSEDI 
inotersen injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61434-031
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
INOTERSEN SODIUM (UNII: 950736UC77) (INOTERSEN - UNII:0IEO0F56LV)	INOTERSEN	284 mg  in 1.5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61434-031-03	800 in 1 CASE	10/05/2018
1		1.5 mL in 1 SYRINGE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		10/05/2018

Labeler - Catalent Indiana, LLC (172209277)