FDA.reportPublic FDA data

NA

Manufacturer
Akcea Therapeutics, Inc.
Effective date
2023-05-24
Label type
BULK INGREDIENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:50:48

Label at a glance#

ProductNA
Active ingredientVOLANESORSEN SODIUM
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Description of ISIS 304801 Drug Substance (Volanesorsen Sodium)Description of ISIS 304801 Drug Substance (Volanesorsen Sodium)Description of ISIS 304801 Drug Substance (Volanesorsen Sodium)

Ionis Part No. 40309

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72126-001-002025-01-30C16284748780-12cef2736-911c-d83d-e063-dadaa90ab31ff5b39f7f-7ee1-74da-e053-2995a90a4f97

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72126-001-00NA11 kg in 1 BOTTLE, PLASTICPOWDER113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72126-001NA (VOLANESORSEN) POWDER [AKCEA THERAPEUTICS, INC.]31 package rows20230526_f5b39f7f-7ee1-74da-e053-2995a90a4f97.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72126-00172126-001-00

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
NameUNIIKind
VOLANESORSEN SODIUM6JON30SLDTACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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