NDC 59762-0117

MESALAMINE

Mesalamine

MESALAMINE is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Greenstone Llc. The primary component is Mesalamine.

Product ID59762-0117_2b66e230-9fa1-42ef-ad61-9e80f94b425d
NDC59762-0117
Product TypeHuman Prescription Drug
Proprietary NameMESALAMINE
Generic NameMesalamine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-05-10
Marketing CategoryNDA AUTHORIZED GENERIC / NDA
Application NumberNDA204412
Labeler NameGreenstone LLC
Substance NameMESALAMINE
Active Ingredient Strength400 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59762-0117-1

180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59762-0117-1)
Marketing Start Date2019-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59762-0117-1 [59762011701]

MESALAMINE CAPSULE, DELAYED RELEASE
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA204412
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-10

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE400 mg/1

OpenFDA Data

SPL SET ID:370bd908-55af-4dfc-8837-913bf73babbd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1368954
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    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

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