FDA.reportPublic FDA data

abiraterone acetate

Product NDC
72603-111
11-digit product format
726030111
Labeler code
72603
Product ID
72603-111_843754c5-046d-4b63-b1d4-344fbb7592fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
NORTHSTAR RX LLC
Application
ANDA209227
Marketing category
ANDA
Marketing start
2022-05-19
Substance
ABIRATERONE ACETATE
Active strength
500 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209227-001ABIRATERONE ACETATEABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16
A209227-002ABIRATERONE ACETATEABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209227-001AB
A209227-002AB

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 22:54:322026-06A209227-001ABIRATERONE ACETATE250MGTABLET / ORALAB2019-10-16a50c72e98297…
2026-08-01 22:54:322026-06A209227-002ABIRATERONE ACETATE500MGTABLET / ORALAB2022-05-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209227-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209227-002AB1a50c72e98297…

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 ACETATENORTHSTAR RX LLC42d5baa8-aca7-49d8-9c24-9d87b707ec202026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209227
application number: ANDA209227
ndc (product): 72603-111
abiraterone acetateABIRATERONE ACETATEGlenmark Pharmaceuticals Inc., USAba32c453-a231-452a-a6d9-b3e57afb2e752026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209227
application number: ANDA209227

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE500 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
1100075Internal RxNorm lookup
1918042Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42d5baa8-aca7-49d8-9c24-9d87b707ec20Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-111-01abiraterone acetate60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-111-01EA - Each72603-111c92f0ec5-5702-42b0-8461-58060e59e22712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-111ABIRATERONE ACETATE TABLET [NORTHSTAR RX LLC]3Current NDC, Legacy NDC, 1 package rows20240103_42d5baa8-aca7-49d8-9c24-9d87b707ec20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100075abiraterone acetate 250 MG Oral TabletPSN42d5baa8-aca7-49d8-9c24-9d87b707ec204
1918042abiraterone acetate 500 MG Oral TabletPSN42d5baa8-aca7-49d8-9c24-9d87b707ec204
1100075abiraterone acetate 250 MG Oral TabletSCD42d5baa8-aca7-49d8-9c24-9d87b707ec204
1918042abiraterone acetate 500 MG Oral TabletSCD42d5baa8-aca7-49d8-9c24-9d87b707ec204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72603-111-017260301110160 TABLET in 1 BOTTLE (72603-111-01) 60 tablet2022-05-190000-00-00NoNoCurrent