Bicalutamide

Product NDC
51407-010
11-digit product format
514070010
Labeler code
51407
Product ID
51407-010_502406d1-aec4-1ceb-e063-6294a90a9c31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bicalutamide
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
NDA020498
Marketing category
NDA
Marketing start
1995-10-04
Substance
BICALUTAMIDE
Active strength
50 mg/1
Pharmacologic classes
Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bicalutamide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BICALUTAMIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0Z3NAU9DP
Rxcui199123

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
18edadb0-25ee-467f-798d-437ee65ee754Product name320150616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-010-30Bicalutamide30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-010-30EA - Each51407-010749ab35a-052c-468b-b065-b6438930345912024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-010BICALUTAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20241120_26e30155-a50b-df14-e063-6394a90a9be4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199123bicalutamide 50 MG Oral TabletPSN26e30155-a50b-df14-e063-6394a90a9be43
199123bicalutamide 50 MG Oral TabletSCD26e30155-a50b-df14-e063-6394a90a9be43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-010-305140700103030 TABLET in 1 BOTTLE (51407-010-30) 30 tablet2024-09-30NoNoCurrent