Bicalutamide

Product NDC
0904-6019
11-digit product format
009046019
Labeler code
0904
Product ID
0904-6019_ca1ad8ef-c41f-4ad8-b451-75cd9068bbdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bicalutamide
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078917
Marketing category
ANDA
Marketing start
2010-05-11
Marketing end
0000-00-00
Substance
BICALUTAMIDE
Active strength
50 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
0904-6019-46EA - Each0904-60194d0e2c72-278b-4aa7-800e-93e0b12c8d7812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BICALUTAMIDEACTIVE INGREDIENTA0Z3NAU9DPBICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
BICALUTAMIDEACTIVE MOIETYA0Z3NAU9DPBICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
HYPROMELLOSE 2910 (5 CPS)INACTIVE INGREDIENTR75537T0T4BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XBICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6019BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]6Legacy NDC20240612_82d4877e-6ebf-4f75-a108-28dc840b07fc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6019-460090460194630 TABLET in 1 BOTTLE (0904-6019-46) 30 tablet2010-05-110000-00-00NoNoCurrent