NDC 51655-400

Ondansetron HCL

Ondansetron Hcl

Ondansetron HCL is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Northwind Pharmaceuticals. The primary component is Ondansetron Hydrochloride.

Product ID51655-400_3b21ffaa-d097-438d-b14b-f403d9f97608
NDC51655-400
Product TypeHuman Prescription Drug
Proprietary NameOndansetron HCL
Generic NameOndansetron Hcl
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2014-03-17
Marketing CategoryANDA / ANDA
Application NumberANDA077851
Labeler NameNorthwind Pharmaceuticals
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/31
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 51655-400-43

3 TABLET, COATED in 1 BOTTLE (51655-400-43)
Marketing Start Date2014-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51655-400-43 [51655040043]

Ondansetron HCL TABLET, COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/31

OpenFDA Data

SPL SET ID:ea33db56-ad0c-40dc-b880-0458aba22862
Manufacturer
UNII
UPC Code
  • 0051655400431
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Ondansetron HCL" or generic name "Ondansetron Hcl"

    NDCBrand NameGeneric Name
    51655-400Ondansetron HCLOndansetron HCL
    80425-0072Ondansetron HCLOndansetron HCL
    80425-0074Ondansetron HCLOndansetron HCL
    80425-0075Ondansetron HCLOndansetron HCL

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