FDA.reportPublic FDA data

NUBEQA

Product NDC
50419-395
11-digit product format
504190395
Labeler code
50419
Product ID
50419-395_fd96ab4c-d7f4-446f-93d8-1dae246a450a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
darolutamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA212099
Marketing category
NDA
Marketing start
2019-07-31
Substance
DAROLUTAMIDE
Active strength
300 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAROLUTAMIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX05U0N2RCO
Rxcui2180330, 2180336

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
97b6cb5b-7fc7-469d-a725-4182b47bf831Product name120200115
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-395-01NUBEQA1 in 1 CARTONTABLET, FILM COATED123
50419-395-01NUBEQA120 in 1 BOTTLETABLET, FILM COATED12023
50419-395-72NUBEQA1 in 1 CARTONTABLET, FILM COATED123
50419-395-72NUBEQA120 in 1 BOTTLETABLET, FILM COATED12023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-395-01EA - Each50419-3959b4de29d-a2ec-4a42-90de-532f3343d32712019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-395NUBEQA (DAROLUTAMIDE) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 4 package rows20241116_1a7cb212-56e4-4b9d-a73d-bfee7fe4735e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2180330darolutamide 300 MG Oral TabletPSN1a7cb212-56e4-4b9d-a73d-bfee7fe4735e23
2180336NUBEQA 300 MG Oral TabletPSN1a7cb212-56e4-4b9d-a73d-bfee7fe4735e23
2180336darolutamide 300 MG Oral Tablet [Nubeqa]SBD1a7cb212-56e4-4b9d-a73d-bfee7fe4735e23
2180330darolutamide 300 MG Oral TabletSCD1a7cb212-56e4-4b9d-a73d-bfee7fe4735e23
2180336Nubeqa 300 MG Oral TabletSY1a7cb212-56e4-4b9d-a73d-bfee7fe4735e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-395-01504190395011 BOTTLE in 1 CARTON (50419-395-01) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-310000-00-00NoNoCurrent
50419-395-72504190395721 BOTTLE in 1 CARTON (50419-395-72) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-03-030000-00-00NoNoCurrent