NDC 0023-5901

Asacol HD

Mesalamine

Asacol HD is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Mesalamine.

Product ID0023-5901_1091e5b4-a430-417a-9922-2edc927406a2
NDC0023-5901
Product TypeHuman Prescription Drug
Proprietary NameAsacol HD
Generic NameMesalamine
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2008-05-28
Marketing CategoryNDA / NDA
Application NumberNDA021830
Labeler NameAllergan, Inc.
Substance NameMESALAMINE
Active Ingredient Strength800 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0023-5901-18

180 TABLET, DELAYED RELEASE in 1 BOTTLE (0023-5901-18)
Marketing Start Date2008-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0023-5901-18 [00023590118]

Asacol HD TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA021830
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-05-28

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE800 mg/1

OpenFDA Data

SPL SET ID:2f68f68c-58d2-4575-b573-f2e62f95d7e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849383
  • 833234
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    NDC Crossover Matching brand name "Asacol HD" or generic name "Mesalamine"

    NDCBrand NameGeneric Name
    0023-5901Asacol HDmesalamine
    0430-0783ASACOL HDmesalamine
    0023-5853Delzicolmesalamine
    0179-0142Lialdamesalamine
    0093-5907MesalamineMesalamine
    0093-9224mesalaminemesalamine
    0378-1375Mesalaminemesalamine
    0378-9230Mesalaminemesalamine
    0472-1915MesalamineMesalamine
    0037-0066Rowasamesalamine
    0037-0022sfRowasamesalamine

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