NDC 70748-214

mesalamine

Mesalamine

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

Product ID70748-214_202e0df4-b636-4644-8ecf-fb998308535c
NDC70748-214
Product TypeHuman Prescription Drug
Proprietary Namemesalamine
Generic NameMesalamine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-04-10
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022301
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameMESALAMINE
Active Ingredient Strength375 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70748-214-16

120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-214-16)
Marketing Start Date2020-04-10
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE375 mg/1

OpenFDA Data

SPL SET ID:a69ce2b9-2866-406d-a365-5b185a269e3e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 825130
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

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

    NDCBrand NameGeneric Name
    0378-7401Mesalaminemesalamine Film Coated
    0378-9230Mesalaminemesalamine
    0591-2245MesalamineMesalamine
    16714-830mesalaminemesalamine
    45802-098MesalamineMesalamine
    45802-923MesalamineMesalamine
    45802-929MesalamineMesalamine
    50090-3497mesalaminemesalamine
    54092-100MesalamineMESALAMINE
    59762-0118Mesalaminemesalamine
    60687-347mesalaminemesalamine
    60687-397MesalamineMesalamine
    60687-408MesalamineMesalamine
    62559-420MesalamineMesalamine
    63304-175MesalamineMesalamine
    68382-435mesalaminemesalamine
    68382-484mesalaminemesalamine
    68382-649mesalaminemesalamine
    68382-711mesalaminemesalamine
    70771-1071mesalaminemesalamine
    70771-1110mesalaminemesalamine
    0093-5907MesalamineMesalamine
    59762-0117MESALAMINEMESALAMINE
    64980-282MesalamineMesalamine
    42291-563MesalamineMesalamine
    42291-564MesalamineMesalamine
    0781-7088MesalamineMesalamine
    0378-1375Mesalaminemesalamine
    68682-113mesalaminemesalamine
    69238-1274MesalamineMesalamine
    70710-1302MesalamineMesalamine
    70771-1513MesalamineMesalamine
    31722-005MesalamineMesalamine
    70748-214mesalaminemesalamine
    43353-884APRISOmesalamine
    65649-103APRISOmesalamine
    53808-0205Asacolmesalamine
    53808-0823ASACOLmesalamine
    55154-2305Asacolmesalamine
    0023-5901Asacol HDmesalamine
    0430-0783ASACOL HDmesalamine
    58914-501CanasaMesalamine
    65084-474CanasaMesalamine
    0023-5853Delzicolmesalamine
    50090-3002Delzicolmesalamine
    68151-5652Delzicolmesalamine
    0179-0142Lialdamesalamine
    54092-476Lialdamesalamine
    69918-560Mesalamine RectalMesalamine
    54092-189Pentasamesalamine

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