NDC 59762-0118

Mesalamine

Mesalamine

Mesalamine is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by Greenstone Llc. The primary component is Mesalamine.

Product ID59762-0118_1f77efd2-58e7-4492-89f3-30a4b43366d9
NDC59762-0118
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2018-12-07
Marketing CategoryNDA AUTHORIZED GENERIC / NDA
Application NumberNDA021252
Labeler NameGreenstone LLC
Substance NameMESALAMINE
Active Ingredient Strength1000 mg/1
Pharm ClassesAminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59762-0118-3

30 SUPPOSITORY in 1 BOX (59762-0118-3)
Marketing Start Date2018-12-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59762-0118-3 [59762011803]

Mesalamine SUPPOSITORY
Marketing CategoryNDA
Application NumberNDA021252
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-07

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE1000 mg/1

OpenFDA Data

SPL SET ID:3ef5c3f6-587e-48ea-a4b4-a7bf1bd749c6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248420
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]
    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    Medicade Reported Pricing

    59762011803 MESALAMINE 1,000 MG SUPP

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0093-5907MesalamineMesalamine
    0093-9224mesalaminemesalamine
    0378-1375Mesalaminemesalamine
    0378-7401Mesalaminemesalamine Film Coated
    0378-9230Mesalaminemesalamine
    68382-711mesalaminemesalamine
    68382-484mesalaminemesalamine
    68382-435mesalaminemesalamine
    68382-649mesalaminemesalamine
    0591-2245MesalamineMesalamine
    70771-1110mesalaminemesalamine
    70771-1071mesalaminemesalamine
    16714-830mesalaminemesalamine
    45802-923MesalamineMesalamine
    45802-929MesalamineMesalamine
    45802-098MesalamineMesalamine
    50090-3497mesalaminemesalamine
    54092-100MesalamineMesalamine
    59762-0118MesalamineMesalamine
    60687-408MesalamineMesalamine
    60687-397MesalamineMesalamine
    60687-347mesalaminemesalamine
    62559-420MesalamineMesalamine
    63304-175MesalamineMesalamine
    59762-0117MESALAMINEMESALAMINE
    64980-282MesalamineMesalamine
    0781-7088MesalamineMesalamine
    42291-564MesalamineMesalamine
    42291-563MesalamineMesalamine
    68682-113mesalaminemesalamine
    0023-5901Asacol HDmesalamine
    0023-5853Delzicolmesalamine
    0179-0142Lialdamesalamine
    0037-0066Rowasamesalamine
    0037-0022sfRowasamesalamine

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