NDC 68382-435

mesalamine

Mesalamine

mesalamine is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Mesalamine.

Product ID68382-435_27ca0008-eae6-4a55-970c-b9c31dc0bcc3
NDC68382-435
Product TypeHuman Prescription Drug
Proprietary Namemesalamine
Generic NameMesalamine
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-08-02
Marketing CategoryANDA / ANDA
Application NumberANDA203286
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameMESALAMINE
Active Ingredient Strength800 mg/1
Pharm ClassesAminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68382-435-28

180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)
Marketing Start Date2018-08-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-435-28 [68382043528]

mesalamine TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203286
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-02

NDC 68382-435-30 [68382043530]

mesalamine TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203286
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-02

NDC 68382-435-77 [68382043577]

mesalamine TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203286
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-02

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE800 mg/1

OpenFDA Data

SPL SET ID:ad8c7930-92e2-4372-a874-da22b9ae333e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 833234

    • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    Medicade Reported Pricing

    68382043528 MESALAMINE 800 MG DR TABLET

    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
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