NDC 33261-417

Ondansetron Hydrochloride

Ondansetron Hydrochloride

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

Product ID33261-417_1156d9cb-4ad2-49c0-b7ee-4b947c5dcc84
NDC33261-417
Product TypeHuman Prescription Drug
Proprietary NameOndansetron Hydrochloride
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA078539
Labeler NameAidarex Pharmaceuticals LLC
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 33261-417-06

6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-417-06)
Marketing Start Date2007-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-417-15 [33261041715]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-31
Inactivation Date2020-01-31

NDC 33261-417-30 [33261041730]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-31
Inactivation Date2020-01-31

NDC 33261-417-05 [33261041705]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-31
Inactivation Date2020-01-31

NDC 33261-417-20 [33261041720]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-31
Inactivation Date2020-01-31

NDC 33261-417-06 [33261041706]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-31
Inactivation Date2020-01-31

NDC 33261-417-12 [33261041712]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-31
Inactivation Date2020-01-31

NDC 33261-417-09 [33261041709]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-31
Inactivation Date2020-01-31

NDC 33261-417-10 [33261041710]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:f51f5405-f7e2-4834-ad43-70987730a0df
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198052
  • 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

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