NDC 35356-500

Amitiza

Lubiprostone

Amitiza is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Lubiprostone.

Product ID35356-500_baf8d3dc-b57f-4bcf-8a75-70ccd3f4e03d
NDC35356-500
Product TypeHuman Prescription Drug
Proprietary NameAmitiza
Generic NameLubiprostone
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2011-06-01
Marketing CategoryNDA / NDA
Application NumberNDA021908
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameLUBIPROSTONE
Active Ingredient Strength24 ug/1
Pharm ClassesChloride Channel Activator [EPC],Chloride Channel Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 35356-500-60

60 CAPSULE, GELATIN COATED in 1 BOTTLE (35356-500-60)
Marketing Start Date2011-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-500-60 [35356050060]

Amitiza CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA021908
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-01

Drug Details

Active Ingredients

IngredientStrength
LUBIPROSTONE24 ug/1

OpenFDA Data

SPL SET ID:417aa15d-ac74-4fa8-a312-6e51e82ba70c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616578
  • 617768

    • Pharmacological Class

    • Chloride Channel Activator [EPC]
    • Chloride Channel Activators [MoA]

    NDC Crossover Matching brand name "Amitiza" or generic name "Lubiprostone"

    NDCBrand NameGeneric Name
    35356-500Amitizalubiprostone
    63629-6398Amitizalubiprostone
    64764-080Amitizalubiprostone
    64764-240Amitizalubiprostone
    68151-5003Amitizalubiprostone
    72189-410AmitzaLubiprostone
    0254-3028LubiprostoneLubiprostone
    0254-3029LubiprostoneLubiprostone
    0480-3479LubiprostoneLubiprostone
    0480-4138LubiprostoneLubiprostone
    10370-266LubiprostoneLubiprostone
    10370-267LubiprostoneLubiprostone
    42291-475LubiprostoneLubiprostone
    42291-476LubiprostoneLubiprostone
    43598-163LubiprostoneLubiprostone
    43598-168LubiprostoneLubiprostone
    55700-963LubiprostoneLubiprostone
    63304-351Lubiprostonelubiprostone
    63304-352Lubiprostonelubiprostone
    65162-841LubiprostoneLubiprostone
    65162-842LubiprostoneLubiprostone
    69339-162LUBIPROSTONELUBIPROSTONE
    69339-163LUBIPROSTONELUBIPROSTONE

    Trademark Results [Amitiza]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMITIZA
    AMITIZA
    78699418 3170145 Live/Registered
    SUCAMPO AG
    2005-08-24
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