NDC 70771-1071

mesalamine

Mesalamine

mesalamine is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Mesalamine.

Product ID70771-1071_0597b64c-aa1f-42bd-8fc0-49fb44ca0124
NDC70771-1071
Product TypeHuman Prescription Drug
Proprietary Namemesalamine
Generic NameMesalamine
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2017-06-19
Marketing CategoryANDA / ANDA
Application NumberANDA091640
Labeler NameCadila Healthcare Limited
Substance NameMESALAMINE
Active Ingredient Strength1 g/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70771-1071-1

120 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1071-1)
Marketing Start Date2017-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1071-1 [70771107101]

mesalamine TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091640
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-19

NDC 70771-1071-2 [70771107102]

mesalamine TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091640
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-19

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE1.2 g/1

OpenFDA Data

SPL SET ID:29c0dd58-d2cf-40fa-bc32-0eab61937331
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 686429
  • 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

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