NDC 35356-679

ONDANSETRON HYDROCHLORIDE

Ondansetron Hydrochloride

ONDANSETRON HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Ondansetron Hydrochloride.

Product ID35356-679_4b7b0d18-4513-470d-9ef0-5d5f491e511c
NDC35356-679
Product TypeHuman Prescription Drug
Proprietary NameONDANSETRON HYDROCHLORIDE
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA077050
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-679-30

30 TABLET, FILM COATED in 1 BOTTLE (35356-679-30)
Marketing Start Date2007-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-679-30 [35356067930]

ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Marketing End Date2019-06-30

NDC 35356-679-10 [35356067910]

ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:e8ff7386-44d0-4bec-8c7a-1b299d18b48f
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.