NDC 51655-415

Ondansetron Hydrochloride

Ondansetron Hydrochloride

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

Product ID51655-415_852a464a-e3ef-c891-e053-2991aa0aae97
NDC51655-415
Product TypeHuman Prescription Drug
Proprietary NameOndansetron Hydrochloride
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-12-07
Marketing CategoryANDA / ANDA
Application NumberANDA078539
Labeler NameNorthwind Pharmaceuticals
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51655-415-04

4 TABLET, FILM COATED in 1 BOTTLE (51655-415-04)
Marketing Start Date2018-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51655-415-55 [51655041555]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-07

NDC 51655-415-43 [51655041543]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-28

NDC 51655-415-87 [51655041587]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-24

NDC 51655-415-53 [51655041553]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-24

NDC 51655-415-04 [51655041504]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-12

NDC 51655-415-54 [51655041554]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-28

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:852a3251-bf28-5557-e053-2991aa0a4fbd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198052

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0054-0064Ondansetron HydrochlorideOndansetron Hydrochloride
    0179-0247Ondansetron HydrochlorideOndansetron Hydrochloride
    0179-0248Ondansetron HydrochlorideOndansetron Hydrochloride
    0527-1726Ondansetron HydrochlorideOndansetron Hydrochloride
    0615-8185ondansetron hydrochlorideondansetron hydrochloride
    0904-6551ondansetron hydrochlorideondansetron hydrochloride
    0904-6552ondansetron hydrochlorideondansetron hydrochloride
    10544-575Ondansetron HydrochlorideOndansetron Hydrochloride
    21695-834ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
    21695-835ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
    68071-1816Ondansetron HydrochlorideOndansetron Hydrochloride
    68071-2147Ondansetron HydrochlorideOndansetron Hydrochloride
    68071-4206Ondansetron HydrochlorideOndansetron Hydrochloride
    68071-4208Ondansetron HydrochlorideOndansetron Hydrochloride
    68071-4328Ondansetron HydrochlorideOndansetron Hydrochloride
    68071-4705Ondansetron HydrochlorideOndansetron Hydrochloride
    68084-220Ondansetron HydrochlorideOndansetron Hydrochloride
    68084-221Ondansetron HydrochlorideOndansetron Hydrochloride
    68151-1668Ondansetron HydrochlorideOndansetron Hydrochloride
    68094-763Ondansetron HydrochlorideOndansetron Hydrochloride
    68788-9368Ondansetron HydrochlorideOndansetron Hydrochloride
    68788-9402Ondansetron HydrochlorideOndansetron Hydrochloride
    68788-9893ondansetron hydrochlorideondansetron hydrochloride
    68788-9892ondansetron hydrochlorideondansetron hydrochloride
    70518-1394Ondansetron HydrochlorideOndansetron Hydrochloride
    70518-1042ondansetron hydrochlorideondansetron hydrochloride
    70518-1585Ondansetron HydrochlorideOndansetron Hydrochloride
    70934-148Ondansetron HydrochlorideOndansetron Hydrochloride
    71335-0205Ondansetron HydrochlorideOndansetron Hydrochloride
    71610-119Ondansetron HydrochlorideOndansetron Hydrochloride
    71872-7138Ondansetron HydrochlorideOndansetron Hydrochloride
    23155-196Ondansetron HydrochlorideOndansetron Hydrochloride
    23155-168Ondansetron HydrochlorideOndansetron Hydrochloride
    23155-377Ondansetron HydrochlorideOndansetron Hydrochloride
    23155-378Ondansetron HydrochlorideOndansetron Hydrochloride
    33261-417Ondansetron HydrochlorideOndansetron Hydrochloride
    35356-679ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
    33261-745Ondansetron HydrochlorideOndansetron Hydrochloride
    36000-012ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
    36000-013ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
    42708-044Ondansetron HydrochlorideOndansetron Hydrochloride
    42708-059Ondansetron HydrochlorideOndansetron Hydrochloride
    43063-792Ondansetron HydrochlorideOndansetron Hydrochloride
    45865-509Ondansetron HydrochlorideOndansetron Hydrochloride
    50090-3185Ondansetron HydrochlorideOndansetron Hydrochloride
    50090-3178Ondansetron HydrochlorideOndansetron Hydrochloride
    50436-0131ondansetron hydrochlorideondansetron hydrochloride
    50436-1880Ondansetron HydrochlorideOndansetron Hydrochloride
    50268-621Ondansetron HydrochlorideOndansetron Hydrochloride
    50268-622Ondansetron HydrochlorideOndansetron Hydrochloride
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