NDC 0456-2410

SAPHRIS

Asenapine Maleate

SAPHRIS is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Asenapine Maleate.

Product ID0456-2410_3f3771cc-64e2-43e7-ac4c-b41d51c77ca9
NDC0456-2410
Product TypeHuman Prescription Drug
Proprietary NameSAPHRIS
Generic NameAsenapine Maleate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2013-09-30
Marketing CategoryNDA / NDA
Application NumberNDA022117
Labeler NameAllergan, Inc.
Substance NameASENAPINE MALEATE
Active Ingredient Strength10 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0456-2410-10

1 CASE in 1 CARTON (0456-2410-10) > 1 BLISTER PACK in 1 CASE > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2013-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0456-2410-63 [00456241063]

SAPHRIS TABLET
Marketing CategoryNDA
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-30

NDC 0456-2410-60 [00456241060]

SAPHRIS TABLET
Marketing CategoryNDA
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-30

NDC 0456-2410-06 [00456241006]

SAPHRIS TABLET
Marketing CategoryNDA
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-11

NDC 0456-2410-10 [00456241010]

SAPHRIS TABLET
Marketing CategoryNDA
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-30

NDC 0456-2410-20 [00456241020]

SAPHRIS TABLET
Marketing CategoryNDA
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-30
Marketing End Date2014-12-05

NDC 0456-2410-11 [00456241011]

SAPHRIS TABLET
Marketing CategoryNDA
Application NumberNDA022117
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-09-30

Drug Details

Active Ingredients

IngredientStrength
ASENAPINE MALEATE10 mg/1

OpenFDA Data

SPL SET ID:5429f134-839f-4ffc-9944-55f51238def8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1606490
  • 859981
  • 859979
  • 859983
  • 859975
  • 1606337

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.