Nilandron

Product NDC
59212-111
11-digit product format
592120111
Labeler code
59212
Product ID
59212-111_e834bedb-32de-4f3a-b9f3-cb5f4804d046
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nilutamide
Dosage form
TABLET
Route
ORAL
Labeler
Concordia Pharmaceuticals Inc.
Application
NDA020169
Marketing category
NDA
Marketing start
2013-07-15
Marketing end
0000-00-00
Substance
NILUTAMIDE
Active strength
150 mg/1
Pharmacologic classes
Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
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
59212-111-14EA - Each59212-111f2e23379-e1eb-49fd-b817-656972e85c8912016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-111NILANDRON (NILUTAMIDE) TABLET [ADVANZ PHARMA (US) CORP.]8Legacy NDC20241210_5ccf0e9a-8935-4c8c-b883-b4967281eb4a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-111-14592120111143 BLISTER PACK in 1 CARTON (59212-111-14) > 10 TABLET in 1 BLISTER PACK3 blister pack2013-07-150000-00-00NoNoCurrent