NDC 63629-6398

Amitiza

Lubiprostone

Amitiza is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Lubiprostone.

Product ID63629-6398_419de2c2-7b0a-4f9b-b150-1711fe26375d
NDC63629-6398
Product TypeHuman Prescription Drug
Proprietary NameAmitiza
Generic NameLubiprostone
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2006-01-31
Marketing CategoryNDA / NDA
Application NumberNDA021908
Labeler NameBryant Ranch Prepack
Substance NameLUBIPROSTONE
Active Ingredient Strength24 ug/1
Pharm ClassesChloride Channel Activator [EPC],Chloride Channel Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-6398-1

90 CAPSULE, GELATIN COATED in 1 BOTTLE (63629-6398-1)
Marketing Start Date2015-09-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-6398-1 [63629639801]

Amitiza CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA021908
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LUBIPROSTONE24 ug/1

OpenFDA Data

SPL SET ID:70b0fe82-92b9-4aee-8aa5-e1e0af003b71
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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