NDC 65483-894

LOTRONEX

Alosetron Hydrochloride

LOTRONEX is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Prometheus Laboratories Inc.. The primary component is Alosetron Hydrochloride.

Product ID65483-894_800b0802-c4e6-409f-adbc-a985d1fca2a5
NDC65483-894
Product TypeHuman Prescription Drug
Proprietary NameLOTRONEX
Generic NameAlosetron Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-02-09
Marketing CategoryNDA / NDA
Application NumberNDA021107
Labeler NamePrometheus Laboratories Inc.
Substance NameALOSETRON HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 65483-894-03

30 TABLET in 1 BOTTLE (65483-894-03)
Marketing Start Date2009-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65483-894-03 [65483089403]

LOTRONEX TABLET
Marketing CategoryNDA
Application NumberNDA021107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-02-09
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ALOSETRON HYDROCHLORIDE.5 mg/1

OpenFDA Data

SPL SET ID:526ba44c-a476-4675-a63c-4d0a72b723f5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403975
  • 259306
  • 540181
  • 261362
    • UPC Code
  • 0365483895032
  • 0365483894035

    • Pharmacological Class

    • Serotonin 3 Receptor Antagonists [MoA]
    • Serotonin-3 Receptor Antagonist [EPC]

    Medicade Reported Pricing

    65483089403 LOTRONEX 0.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "LOTRONEX" or generic name "Alosetron Hydrochloride"

    NDCBrand NameGeneric Name
    54766-894LOTRONEXalosetron hydrochloride
    54766-895LOTRONEXalosetron hydrochloride
    65483-894LOTRONEXalosetron hydrochloride
    65483-895LOTRONEXalosetron hydrochloride
    0054-0295Alosetron Hydrochloridealosetron hydrochloride
    0054-0296Alosetron Hydrochloridealosetron hydrochloride
    42291-123Alosetron HydrochlorideAlosetron Hydrochloride
    42291-124Alosetron HydrochlorideAlosetron Hydrochloride
    45963-479Alosetron Hydrochloridealosetron hydrochloride
    45963-480Alosetron Hydrochloridealosetron hydrochloride
    49884-819ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDE
    49884-820ALOSETRON HYDROCHLORIDEALOSETRON HYDROCHLORIDE
    64980-453alosetron hydrochloridealosetron hydrochloride
    64980-454alosetron hydrochloridealosetron hydrochloride
    65162-248Alosetron HydrochlorideAlosetron Hydrochloride
    65162-249Alosetron HydrochlorideAlosetron Hydrochloride

    Trademark Results [LOTRONEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LOTRONEX
    LOTRONEX
    75294530 2238126 Live/Registered
    SEBELA IRELAND LIMITED
    1997-05-19
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