NDC 0054-0295

Alosetron Hydrochloride

Alosetron Hydrochloride

Alosetron Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Alosetron Hydrochloride.

Product ID0054-0295_113b5615-f978-4d29-b5c8-f29f3d3f656b
NDC0054-0295
Product TypeHuman Prescription Drug
Proprietary NameAlosetron Hydrochloride
Generic NameAlosetron Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA200652
Labeler NameWest-Ward Pharmaceuticals Corp.
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 0054-0295-13

30 TABLET in 1 BOTTLE (0054-0295-13)
Marketing Start Date2015-05-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0295-13 [00054029513]

Alosetron Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA200652
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-05-04

Drug Details

Active Ingredients

IngredientStrength
ALOSETRON HYDROCHLORIDE.5 mg/1

OpenFDA Data

SPL SET ID:e91c4a69-2ad5-4e21-a279-9e1302b1a3d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403975
  • 259306
    • UPC Code
  • 0300540295134
  • 0300540296131

    • 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
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