NUBEQA
These highlights do not include all the information needed to use NUBEQA safely and effectively. See full prescribing information for NUBEQA.NUBEQA (darolutamide) tablets, for oral useInitial U.S. Approval: 2019
Approved
Approval ID
1a7cb212-56e4-4b9d-a73d-bfee7fe4735e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Bayer HealthCare Pharmaceuticals Inc.
DUNS: 005436809
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
darolutamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-395
Application NumberNDA212099
Product Classification
M
Marketing Category
C73594
G
Generic Name
darolutamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2021
FDA Product Classification
INGREDIENTS (8)
DAROLUTAMIDEActive
Quantity: 300 mg in 1 1
Code: X05U0N2RCO
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT