Source: FDA, National Drug Code (US) Revision Year: 2019
NUBEQA is an androgen receptor inhibitor. The chemical name is N-{(2S)1[3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl]propan-2-yl}5(1-hydroxyethyl)-1H-pyrazole-3-carboxamide.
The molecular weight is 398.85 and the molecular formula is C19H19ClN6O2.
The structural formula is:
Darolutamide is an optically active with a specific rotation value [α]20D= 72.2 o*mL/(dm*g), white to greyish- or yellowish white crystalline powder, that is soluble in tetrahydrofuran, but practically insoluble in aqueous medium. Darolutamide has a pKa of 11.75.
NUBEQA (darolutamide) is supplied as film-coated tablets containing 300 mg of darolutamide for oral use. The inactive ingredients of the tablet are: calcium hydrogen phosphate, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone K 30, hypromellose 15 cP, macrogol 3350, and titanium dioxide.
| Dosage Forms and Strengths |
|---|
|
Tablets (300 mg): white to off-white oval film-coated tablets marked with “300” on one side and “Bayer” on the other. |
| How Supplied |
|---|
|
NUBEQA (darolutamide) 300 mg film-coated tablets are white to off-white, oval shaped tablets, marked with “300” on one side, and “BAYER” on the other side. NUBEQA 300 mg tablets are available in bottles of 120 tablets. NDC 50419-395-01 |
| Drug | Countries | |
|---|---|---|
| NUBEQA | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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