Abiraterone acetate

Product NDC
64679-021
11-digit product format
646790021
Labeler code
64679
Product ID
64679-021_6a5aa169-f0f0-432b-b0d2-4f5f0a491cec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Abiraterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA208380
Marketing category
ANDA
Marketing start
2019-02-27
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64679-021-012023-11-29C16284748780-1f386c649-f387-0266-e053-dadaa90a7c1a76f9bb2f-4946-4391-9e7d-e4f867cf84db
64679-021-012023-01-30C16284748780-1f386c649-f387-0266-e053-dadaa90a7c1a76f9bb2f-4946-4391-9e7d-e4f867cf84db

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-021-01EA - Each64679-021eee628d8-bcc5-4a9d-8e77-0e3c3816d63112019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-021-0164679002101120 TABLET in 1 BOTTLE (64679-021-01) 120 tablet2019-02-270000-00-00NoNoCurrent