Abiraterone Acetate

Product NDC
42292-057
11-digit product format
422920057
Labeler code
42292
Product ID
42292-057_d3aef164-ffc6-d7a6-e053-2a95a90a5711
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA208446
Marketing category
ANDA
Marketing start
2020-06-03
Marketing end
2022-02-28
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42292-057-01EA - Each42292-0572a12e42d-f1c4-4353-8c69-bc76c56844e912020-07-13
42292-057-03EA - Each42292-057544cba86-c958-4cac-b80d-1c9349f2bd3e12020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42292-057-034229200570330 BLISTER PACK in 1 CARTON (42292-057-03) > 1 TABLET in 1 BLISTER PACK (42292-057-01) 30 blister pack2020-06-030000-00-00NoNoCurrent