Abiraterone Acetate

Product NDC
0093-1125
11-digit product format
000931125
Labeler code
0093
Product ID
0093-1125_81772086-cab1-4658-8132-d0650a06a4c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone Acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA208432
Marketing category
ANDA
Marketing start
2018-11-21
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
0093-1125-89EA - Each0093-11253abf8086-3926-475a-a68c-96a7c9c17eb912018-12-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-1125-8900093112589120 TABLET, FILM COATED in 1 BOTTLE (0093-1125-89) 2018-11-210000-00-00NoNoCurrent