Source: FDA, National Drug Code (US) Revision Year: 2017
SAPHRIS contains asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its molecular formula is C17H16ClNO•C4H4O4 and its molecular weight is 401.84 (free base: 285.8).
The chemical structure is:
Asenapine maleate is a white to off-white powder.
SAPHRIS, black cherry flavor, is supplied for sublingual administration in tablets containing 2.5 mg, 5 mg or 10 mg asenapine; inactive ingredients include gelatin, mannitol, sucralose, and black cherry flavor.
| Dosage Forms and Strengths |
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| How Supplied |
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SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavor: Round, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging: Box of 60 6 blisters with 10 tablets NDC 0456-2402-60 Hospital Unit Dose: Box of 100 10 blisters with 10 tablets NDC 0456-2402-63 5 mg Tablets, black cherry flavor: Round, white to off-white sublingual tablets, with “5” on one side within a circle. Child-resistant packaging: Box of 60 6 blisters with 10 tablets NDC 0456-2405-60 Hospital Unit Dose: Box of 100 10 blisters with 10 tablets NDC 0456-2405-63 10 mg Tablets, black cherry flavor: Round, white to off-white sublingual tablets, with “10” on one side within a circle. Child-resistant packaging: Box of 60 6 blisters with 10 tablets NDC 0456-2410-60 Hospital Unit Dose: Box of 100 10 blisters with 10 tablets NDC 0456-2410-63 Distributed by: Allergan USA, Inc., Irvine, CA 92612 |
| Drug | Countries | |
|---|---|---|
| SAPHRIS | Australia, Canada, Israel, New Zealand, United States |
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