FDA.reportPublic FDA data

Bicalutamide

Product NDC
63629-8308
11-digit product format
636298308
Labeler code
63629
Product ID
63629-8308_01c32f48-8661-4d25-8e50-c6c97180cc42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bicalutamide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078917
Marketing category
ANDA
Marketing start
2009-07-06
Substance
BICALUTAMIDE
Active strength
50 mg/1
Pharmacologic classes
Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bicalutamide
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-8308-12024-05-10C16284748780-11030e365-3bcb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE TABLETS, for oral use Initial U.S. Approval: 1995
63629-8308-22024-05-10C16284748780-11030e365-3bcb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE TABLETS, for oral use Initial U.S. Approval: 1995
63629-8308-12024-01-30C16284748780-11030e365-3bcb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE TABLETS, for oral use Initial U.S. Approval: 1995
63629-8308-22024-01-30C16284748780-11030e365-3bcb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE TABLETS, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8308-1Bicalutamide30 in 1 BOTTLETABLET303
63629-8308-2Bicalutamide100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8308BICALUTAMIDE TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 2 package rows20240511_6d27f9b0-6b93-42fa-807e-fc819c0da14f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199123bicalutamide 50 MG Oral TabletPSN6d27f9b0-6b93-42fa-807e-fc819c0da14f3
199123bicalutamide 50 MG Oral TabletSCD6d27f9b0-6b93-42fa-807e-fc819c0da14f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8308-16362983080130 TABLET in 1 BOTTLE (63629-8308-1) 30 tablet2021-06-080000-00-00NoNoCurrent
63629-8308-263629830802100 TABLET in 1 BOTTLE (63629-8308-2) 100 tablet2020-03-160000-00-00NoNoCurrent