NDC 0052-0119

SAPHRIS

Asenapine Maleate

SAPHRIS is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Organon Pharmaceuticals Usa. The primary component is Asenapine Maleate.

Product ID0052-0119_da55e2fe-c473-46cc-a4b4-d31c8e63d148
NDC0052-0119
Product TypeHuman Prescription Drug
Proprietary NameSAPHRIS
Generic NameAsenapine Maleate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2009-08-13
Marketing CategoryNDA / NDA
Application NumberNDA022117
Labeler NameOrganon Pharmaceuticals USA
Substance NameASENAPINE MALEATE
Active Ingredient Strength10 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0052-0119-90

10 BLISTER PACK in 1 CARTON (0052-0119-90) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2009-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0052-0119-06 [00052011906]

SAPHRIS TABLET
Marketing CategoryNDA
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-13
Inactivation Date2020-01-31

NDC 0052-0119-82 [00052011982]

SAPHRIS TABLET
Marketing CategoryNDA
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-13
Inactivation Date2020-01-31

NDC 0052-0119-90 [00052011990]

SAPHRIS TABLET
Marketing CategoryNDA
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ASENAPINE MALEATE10 mg/1

OpenFDA Data

SPL SET ID:17209c32-56eb-4f84-954d-aed7b7a1b18d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859975
  • 859981
  • 859979
  • 859983

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "SAPHRIS" or generic name "Asenapine Maleate"

    NDCBrand NameGeneric Name
    0052-0118SAPHRISAsenapine Maleate
    0052-0119SAPHRISAsenapine Maleate
    0052-2139SAPHRISAsenapine Maleate
    0052-2142SAPHRISAsenapine Maleate
    0456-2402SAPHRISAsenapine Maleate
    0456-2405SAPHRISAsenapine Maleate
    0456-2410SAPHRISAsenapine Maleate
    51991-358AsenapineASENAPINE MALEATE
    51991-359AsenapineASENAPINE MALEATE
    51991-360AsenapineASENAPINE MALEATE
    51991-361AsenapineASENAPINE MALEATE
    51991-928AsenapineASENAPINE MALEATE
    59762-1091Asenapineasenapine maleate
    59762-2012Asenapineasenapine maleate
    59762-2888Asenapineasenapine maleate
    69539-057AsenapineASENAPINE MALEATE
    69539-058AsenapineASENAPINE MALEATE
    69539-059AsenapineASENAPINE MALEATE
    69539-060AsenapineASENAPINE MALEATE
    69539-245AsenapineASENAPINE MALEATE
    64330-625Asenapine MaleateAsenapine Maleate

    Trademark Results [SAPHRIS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SAPHRIS
    SAPHRIS
    79002251 2942245 Live/Registered
    MERCK SHARP & DOHME B.V.
    2004-04-05
    SAPHRIS
    SAPHRIS
    77666398 3865200 Live/Registered
    MERCK SHARP & DOHME B.V.
    2009-02-09
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