HYRNUO Film-coated tablet Ref.[116094] Active ingredients: Sevabertinib
Source: FDA, National Drug Code (US) Revision Year: 2025
Product description
HYRNUO tablets contain sevabertinib, a kinase inhibitor. The chemical name of the drug substance is 3-(3-chloro-2-methoxyanilino)-2-{3-[(2S)-1,4-dioxan-2-ylmethoxy]pyridin-4-yl}-1,5,6,7-tetrahydro-4H-pyrrolo[3,2-c]pyridin-4-one hydrate. The molecular formula is C24H25ClN4O5 (anhydrate) and the molecular weight is 484.93 g/mol (anhydrate).
The structural formula is shown below:
Sevabertinib is present as a non-stoichiometric hydrate as a white to off-white to yellow to pinkish powder. It is slightly soluble in aqueous solution at pH 2, and practically insoluble in aqueous solutions at pH 4.5 and above.
The strength of HYRNUO is based on the anhydrate form. Each HYRNUO tablet for oral use contains 10 mg of sevabertinib. The inactive ingredients are: cellulose microcrystalline, crospovidone, lactose monohydrate, and magnesium stearate. The tablet film coating contains ferric oxide red, hypromellose 5 cP, and macrogol 3350.
| Dosage Forms and Strengths |
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Tablets: red brown film-coated, round, biconvex tablets debossed with "SE" on one side and "10" on the other side containing 10 mg of sevabertinib. |
| How Supplied |
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HYRNUO 10 mg tablets are supplied as red brown film-coated, round, biconvex tablets debossed with "SE" on one side and "10" on the other side. HYRNUO tablets are packaged in a HDPE bottle of 120 tablets closed with a child-resistant screw cap. NDC 50419-397-01 Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981 USA |
Drugs
| Drug | Countries | |
|---|---|---|
| HYRNUO | United States |
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