NDC 65649-103

APRISO

Mesalamine

APRISO is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Salix Pharmaceuticals, Inc.. The primary component is Mesalamine.

Product ID65649-103_2c65581d-cb5c-478c-958f-7007433af350
NDC65649-103
Product TypeHuman Prescription Drug
Proprietary NameAPRISO
Generic NameMesalamine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-10-31
Marketing CategoryNDA / NDA
Application NumberNDA022301
Labeler NameSalix Pharmaceuticals, Inc.
Substance NameMESALAMINE
Active Ingredient Strength375 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65649-103-01

1 BOTTLE in 1 CARTON (65649-103-01) > 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2008-10-31
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 65649-103-02 [65649010302]

APRISO CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022301
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-10-31

NDC 65649-103-01 [65649010301]

APRISO CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022301
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-31

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE375 mg/1

OpenFDA Data

SPL SET ID:7951139c-b271-45a4-b523-34b23800917b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 825134
  • 825130
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    Medicade Reported Pricing

    65649010302 APRISO ER 0.375 GRAM CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "APRISO" or generic name "Mesalamine"

    NDCBrand NameGeneric Name
    43353-884APRISOAPRISO
    65649-103APRISOAPRISO
    0023-5901Asacol HDmesalamine
    0430-0783ASACOL HDmesalamine
    0023-5853Delzicolmesalamine
    0179-0142Lialdamesalamine
    0093-5907MesalamineMesalamine
    0093-9224mesalaminemesalamine
    0378-1375Mesalaminemesalamine
    0378-9230Mesalaminemesalamine
    0472-1915MesalamineMesalamine
    0037-0066Rowasamesalamine
    0037-0022sfRowasamesalamine

    Trademark Results [APRISO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    APRISO
    APRISO
    77520068 3743051 Live/Registered
    Salix Pharmaceuticals, Ltd.
    2008-07-11
    APRISO
    APRISO
    76333591 2682873 Live/Registered
    APRISO CORP.
    2001-11-02

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.