NDC 0378-9230

Mesalamine

Mesalamine

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

Product ID0378-9230_06e73687-d79a-4c57-9641-19ef1cfe5f24
NDC0378-9230
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2018-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA204354
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMESALAMINE
Active Ingredient Strength1000 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-9230-93

5 PACKAGE in 1 CARTON (0378-9230-93) > 6 SUPPOSITORY in 1 PACKAGE
Marketing Start Date2018-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-9230-93 [00378923093]

Mesalamine SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA204354
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-17

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE1000 mg/1

OpenFDA Data

SPL SET ID:9a81fe63-08f5-45a6-bbe4-a4ac4a04bab4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248420
  • 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

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