abiraterone acetate

Product NDC
72603-110
11-digit product format
726030110
Labeler code
72603
Product ID
72603-110_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
2022-03-07
Substance
ABIRATERONE ACETATE
Active strength
250 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABIRATERONE ACETATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEM5OCB9YJ6
Rxcui1100075, 1918042

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
72603-110-01abiraterone acetate120 in 1 BOTTLETABLET1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-110-01EA - Each72603-110ce9c249c-63aa-4ca8-91e6-ed9b783bd5e512022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-110ABIRATERONE 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
72603-110-0172603011001120 TABLET in 1 BOTTLE (72603-110-01) 120 tablet2022-03-070000-00-00NoNoCurrent