Bicalutamide

Product NDC
71205-577
11-digit product format
712050577
Labeler code
71205
Product ID
71205-577_d8a5e670-a721-42c1-a384-4efe056f3a65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bicalutamide
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-577-30Bicalutamide30 in 1 BOTTLETABLET302
71205-577-60Bicalutamide60 in 1 BOTTLETABLET602
71205-577-90Bicalutamide90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-577BICALUTAMIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20221112_c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199123bicalutamide 50 MG Oral TabletPSNc5c04006-0078-4fd7-9ecd-c50d8d9fa5d62
199123bicalutamide 50 MG Oral TabletSCDc5c04006-0078-4fd7-9ecd-c50d8d9fa5d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-577-307120505773030 TABLET in 1 BOTTLE (71205-577-30) 30 tablet2021-06-090000-00-00NoNoCurrent
71205-577-607120505776060 TABLET in 1 BOTTLE (71205-577-60) 60 tablet2021-06-090000-00-00NoNoCurrent
71205-577-907120505779090 TABLET in 1 BOTTLE (71205-577-90) 90 tablet2021-06-090000-00-00NoNoCurrent