Abiraterone Acetate

Product NDC
63629-9430
11-digit product format
636299430
Labeler code
63629
Product ID
63629-9430_69a2c18e-f623-43fd-bd10-ed154dcc5b9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abiraterone acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215947
Marketing category
ANDA
Marketing start
2022-01-05
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9430-1EA - Each63629-94304745e38b-9eae-4215-a7e5-644b97e85d6612022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9430-16362994300160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9430-1) 2022-08-230000-00-00NoNoCurrent