NDC 64980-453

alosetron hydrochloride

Alosetron Hydrochloride

alosetron hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is Alosetron Hydrochloride.

Product ID64980-453_485cb247-48d8-4bc3-b16b-a0abadea856b
NDC64980-453
Product TypeHuman Prescription Drug
Proprietary Namealosetron hydrochloride
Generic NameAlosetron Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-01-14
Marketing CategoryANDA / ANDA
Application NumberANDA209180
Labeler NameRising Pharmaceuticals, 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 Through2022-12-31

Packaging

NDC 64980-453-03

30 TABLET in 1 BOTTLE (64980-453-03)
Marketing Start Date2019-01-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64980-453-50 [64980045350]

alosetron hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA209180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-14

NDC 64980-453-03 [64980045303]

alosetron hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA209180
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-14

Drug Details

Active Ingredients

IngredientStrength
ALOSETRON HYDROCHLORIDE.5 mg/1

OpenFDA Data

SPL SET ID:7a6c2fbb-a76a-497e-8cf2-a6dca8945a9d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403975
  • 259306

    • 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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