NDC 61919-465

ONDANSETRON HYDROCHLORIDE

Ondansetron Hydrochloride

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

Product ID61919-465_34659398-1c42-27dd-e054-00144ff8d46c
NDC61919-465
Product TypeHuman Prescription Drug
Proprietary NameONDANSETRON HYDROCHLORIDE
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA077851
Labeler NameDIRECT RX
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-465-60

60 TABLET, FILM COATED in 1 BOTTLE (61919-465-60)
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-465-60 [61919046560]

ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-01

NDC 61919-465-06 [61919046506]

ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-01

NDC 61919-465-30 [61919046530]

ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

NDC 61919-465-10 [61919046510]

ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-01

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:2c94fed2-f880-44a9-8d10-93fa5713dcb4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312086
  • Pharmacological Class

    • 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

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