NDC 42291-563

Mesalamine

Mesalamine

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

Product ID42291-563_910903e8-0621-c4c8-e053-2995a90a02e8
NDC42291-563
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA207873
Labeler NameAvKARE, Inc
Substance NameMESALAMINE
Active Ingredient Strength400 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42291-563-18

180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42291-563-18)
Marketing Start Date2019-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-563-18 [42291056318]

Mesalamine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207873
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-26

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE400 mg/1

OpenFDA Data

SPL SET ID:9109035c-2fb6-3e51-e053-2a95a90a7c07
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1368954
  • Pharmacological Class

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