NDC 42291-124

Alosetron Hydrochloride

Alosetron Hydrochloride

Alosetron Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc.. The primary component is Alosetron Hydrochloride.

Product ID42291-124_687dc053-5d61-cdce-e053-2991aa0a8e37
NDC42291-124
Product TypeHuman Prescription Drug
Proprietary NameAlosetron Hydrochloride
Generic NameAlosetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-02-23
Marketing CategoryANDA / ANDA
Application NumberANDA206647
Labeler NameAvKARE, Inc.
Substance NameALOSETRON HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42291-124-30

30 TABLET, FILM COATED in 1 BOTTLE (42291-124-30)
Marketing Start Date2017-02-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-124-30 [42291012430]

Alosetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206647
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-23
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
ALOSETRON HYDROCHLORIDE1 mg/1

OpenFDA Data

SPL SET ID:c0b3bb8c-ce68-4388-ac8d-9de70bce5fb1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403975
  • 259306
  • UPC Code
  • 0342291124301
  • 0342291123304
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    54766-894LOTRONEXalosetron hydrochloride
    54766-895LOTRONEXalosetron hydrochloride
    65483-894LOTRONEXalosetron hydrochloride
    65483-895LOTRONEXalosetron hydrochloride

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