FDA.reportPublic FDA data

YONSA (abiraterone acetate) tablets

Manufacturer
Catalent Pharma Solutions, LLC | Catalent Greenville, Inc. | Sterling Chemical Malta Ltd
Effective date
2025-09-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:43:53

Label at a glance#

ProductYONSA
Active ingredientABIRATERONE ACETATE
Label structure1 sections

Label contents#

Full prescribing information#

Package/Label Display Panel Yonsa 125mg tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle-labelbottle-label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e8e8aba9-b811-8b6a-ff1e-1aec10655d95Product name820240223
8f213b7a-23f6-497c-a54d-8a37f1798781Product name120231023
fb7d5d26-0d70-42a5-a005-42898b3cfc3fProduct name120180730

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
11014-056611014-0566-1

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
ABIRATERONE ACETATEEM5OCB9YJ6ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3f63f522-2a75-f55c-e063-6394a90a663bec93b41f-88c2-e7ab-e053-2a95a90a636d2025-09-22Exact identifier
spl id: 3f63f522-2a75-f55c-e063-6394a90a663b
spl set id: ec93b41f-88c2-e7ab-e053-2a95a90a636d

Reported adverse events (FAERS/openFDA)#

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