NDC 63187-636

Ondansetron Hydrochloride

Ondansetron Hydrochloride

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

Product ID63187-636_2996955e-2b6c-4702-8c4a-6ab17c9e6e87
NDC63187-636
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 NameProficient Rx LP
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63187-636-01

1 TABLET, FILM COATED in 1 BOTTLE (63187-636-01)
Marketing Start Date2018-09-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-636-06 [63187063606]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-01

NDC 63187-636-15 [63187063615]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-02

NDC 63187-636-03 [63187063603]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-01

NDC 63187-636-12 [63187063612]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-04

NDC 63187-636-10 [63187063610]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-02

NDC 63187-636-30 [63187063630]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-02

NDC 63187-636-20 [63187063620]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-02

NDC 63187-636-01 [63187063601]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-04

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:381b44e7-a5a1-42ad-bcea-1ab4c82ff5d4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198052

    • 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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