FDA.reportPublic FDA data

Abiraterone Acetate

Product NDC
0378-6921
11-digit product format
003786921
Labeler code
0378
Product ID
0378-6921_18e5ffff-c938-46e0-bf7a-1c1ab44e8a6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA208446
Marketing category
ANDA
Marketing start
2020-12-14
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

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 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
0378-6921-91Abiraterone Acetate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6921-91EA - Each0378-6921dd8499c2-07d0-470c-8f4e-23c1471de4dd12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6921ABIRATERONE ACETATE TABLET, FILM COATED ABIRATERONE ACETATE TABLET [MYLAN PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 1 package rows20250522_fe02db79-fa04-441f-b514-70bd74af6624.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1918042abiraterone acetate 500 MG Oral TabletPSN79082b18-adde-4ffb-832a-b8c1d030c413100
1918042abiraterone acetate 500 MG Oral TabletSCD79082b18-adde-4ffb-832a-b8c1d030c413100
1100075abiraterone acetate 250 MG Oral TabletPSNfe02db79-fa04-441f-b514-70bd74af662410
1918042abiraterone acetate 500 MG Oral TabletPSNfe02db79-fa04-441f-b514-70bd74af662410
1100075abiraterone acetate 250 MG Oral TabletSCDfe02db79-fa04-441f-b514-70bd74af662410
1918042abiraterone acetate 500 MG Oral TabletSCDfe02db79-fa04-441f-b514-70bd74af662410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-6921-910037869219160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6921-91) 2020-12-140000-00-00NoNoCurrent