FDA.reportPublic FDA data

YONSA

Product NDC
47335-401
11-digit product format
473350401
Labeler code
47335
Product ID
47335-401_5936666c-b89c-4feb-9146-74877fd9b679
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA210308
Marketing category
NDA
Marketing start
2018-05-22
Substance
ABIRATERONE ACETATE
Active strength
125 mg/1
Pharmacologic classes
Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210308-001YONSAABIRATERONE ACETATE125MGTABLET / ORALRLD, RS2018-05-22

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210308-00198891442034-03-17Drug product2018-07-19
N210308-001102929902034-05-20U-25352019-05-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N210308-001YONSA125MGTABLET / ORALRLD, RS2018-05-22a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N210308-00198891442034-03-17Drug product2018-07-19a50c72e98297…
2026-08-01 22:54:322026-06N210308-001102929902034-05-20U-25352019-05-31a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABIRATERONE ACETATEABIRATERONE ACETATEGolden State Medical Supply, Inc.445e70a1-25bd-8fc1-e063-6394a90a1a432026-06-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 210308
application number: NDA210308
YONSAABIRATERONE ACETATESun Pharmaceutical Industries, Inc.b8967e10-f768-47ce-ac9e-2324c83901322026-06-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 210308
application number: NDA210308
ndc (product): 47335-401

Additional Listing Data#

Finished product
Yes
Brand name base
YONSA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EM5OCB9YJ6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2046579Internal RxNorm lookup
2046585Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8967e10-f768-47ce-ac9e-2324c8390132Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47335-401-812020-07-31C16284748780-1ab0e2407-2a88-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use YONSA safely and effectively. See full prescribing information for YONSA. YONSA ® (abiraterone acetate) tablets, for oral use Initial U.S. Approval: 2011
47335-401-812020-07-31C16284748780-1ab0e2407-2a88-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use YONSA safely and effectively. See full prescribing information for YONSA. YONSA ® (abiraterone acetate) tablets, for oral use Initial U.S. Approval: 2011
47335-401-812020-07-31C16284748780-1ab0e2407-2a88-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use YONSA safely and effectively. See full prescribing information for YONSA. YONSA ® (abiraterone acetate) tablets, for oral use Initial U.S. Approval: 2011
47335-401-812020-07-22C16284748780-1ab0e2407-2a88-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use YONSA safely and effectively. See full prescribing information for YONSA. YONSA ® (abiraterone acetate) tablets, for oral use Initial U.S. Approval: 2011
47335-401-812020-07-22C16284748780-1ab0e2407-2a88-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use YONSA safely and effectively. See full prescribing information for YONSA. YONSA ® (abiraterone acetate) tablets, for oral use Initial U.S. Approval: 2011
47335-401-812020-07-22C16284748780-1ab0e2407-2a88-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use YONSA safely and effectively. See full prescribing information for YONSA. YONSA ® (abiraterone acetate) tablets, for oral use Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-401-81YONSA120 in 1 BOTTLE, PLASTICTABLET12013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-401-81EA - Each47335-401e86b38fb-ef6c-4d1e-b7b2-71918d70628012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-401YONSA (ABIRATERONE ACETATE) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 1 package rows20230714_b8967e10-f768-47ce-ac9e-2324c8390132.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2046579abiraterone acetate 125 MG Oral TabletPSNb8967e10-f768-47ce-ac9e-2324c839013213
2046585Yonsa 125 MG Oral TabletPSNb8967e10-f768-47ce-ac9e-2324c839013213
2046585abiraterone acetate 125 MG Oral Tablet [Yonsa]SBDb8967e10-f768-47ce-ac9e-2324c839013213
2046579abiraterone acetate 125 MG Oral TabletSCDb8967e10-f768-47ce-ac9e-2324c839013213
2046585Yonsa 125 MG Oral TabletSYb8967e10-f768-47ce-ac9e-2324c839013213
2046579abiraterone acetate 125 MG Oral TabletPSN445e70a1-25bd-8fc1-e063-6394a90a1a432
2046579abiraterone acetate 125 MG Oral TabletSCD445e70a1-25bd-8fc1-e063-6394a90a1a432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-401-8147335040181120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81) 120 tablet2018-05-220000-00-00NoNoCurrent