NDC 68151-5003

Amitiza

Lubiprostone

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

Product ID68151-5003_fa77ef52-a1a1-485e-96d4-cf2ff432a991
NDC68151-5003
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 NameCarilion Materials Management
Substance NameLUBIPROSTONE
Active Ingredient Strength24 ug/1
Pharm ClassesChloride Channel Activator [EPC],Chloride Channel Activators [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68151-5003-6

1 CAPSULE, GELATIN COATED in 1 PACKAGE (68151-5003-6)
Marketing Start Date2006-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68151-5003-6 [68151500306]

Amitiza CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA021908
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-01-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LUBIPROSTONE24 ug/1

OpenFDA Data

SPL SET ID:1b632d92-a05b-42d3-88a6-b3e345d11fe4
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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