Abiraterone acetate

Product NDC
57894-155
11-digit product format
578940155
Labeler code
57894
Product ID
57894-155_85c1da76-b9c5-4e17-bc0d-7814f644cd4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Janssen Biotech, Inc.
Application
NDA202379
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-02-09
Marketing end
0000-00-00
Substance
ABIRATERONE ACETATE
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-155-12EA - Each57894-1550be096d3-8dc3-429b-85ed-7b37f9af6a8a12018-12-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57894-155-1257894015512120 TABLET in 1 BOTTLE (57894-155-12) 120 tablet2018-02-090000-00-00NoNoCurrent