NDC 54092-476

Lialda

Mesalamine

Lialda is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Shire Us Manufacturing Inc.. The primary component is Mesalamine.

Product ID54092-476_0fe0314c-771b-45d5-ac5b-9879eb121aba
NDC54092-476
Product TypeHuman Prescription Drug
Proprietary NameLialda
Generic NameMesalamine
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2007-01-16
Marketing CategoryNDA / NDA
Application NumberNDA022000
Labeler NameShire US Manufacturing Inc.
Substance NameMESALAMINE
Active Ingredient Strength1 g/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54092-476-01

120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)
Marketing Start Date2007-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-476-02 [54092047602]

Lialda TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022000
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-01-16

NDC 54092-476-08 [54092047608]

Lialda TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022000
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-01-16

NDC 54092-476-12 [54092047612]

Lialda TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022000
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-01-16

NDC 54092-476-01 [54092047601]

Lialda TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022000
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-01-16

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE1.2 g/1

OpenFDA Data

SPL SET ID:3098a080-be86-4265-9818-7fc4beab77b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 686433
  • 686429
  • UPC Code
  • 0354092476015
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    Medicade Reported Pricing

    54092047612 LIALDA DR 1.2 GM TABLET

    Pricing Unit: EA | Drug Type:

    54092047602 LIALDA DR 1.2 GM TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Lialda" or generic name "Mesalamine"

    NDCBrand NameGeneric Name
    0179-0142Lialdamesalamine
    54092-476LialdaLialda
    0023-5901Asacol HDmesalamine
    0430-0783ASACOL HDmesalamine
    0023-5853Delzicolmesalamine
    0093-5907MesalamineMesalamine
    0093-9224mesalaminemesalamine
    0378-1375Mesalaminemesalamine
    0378-9230Mesalaminemesalamine
    0472-1915MesalamineMesalamine
    0037-0066Rowasamesalamine
    0037-0022sfRowasamesalamine

    Trademark Results [Lialda]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LIALDA
    LIALDA
    78931647 3555440 Live/Registered
    Shire LLC
    2006-07-18
    LIALDA
    LIALDA
    78708413 3415795 Live/Registered
    NOGRA PHARMA LIMITED
    2005-09-07

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