NDC 53002-0600

ondansetron

Ondansetron Hydrochloride

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

Product ID53002-0600_5f3aa8c9-1704-42ab-ac93-4684c6a84446
NDC53002-0600
Product TypeHuman Prescription Drug
Proprietary Nameondansetron
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA077851
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-0600-1

3 TABLET, FILM COATED in 1 BOTTLE (53002-0600-1)
Marketing Start Date2017-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-0600-4 [53002060004]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

NDC 53002-0600-3 [53002060003]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

NDC 53002-0600-2 [53002060002]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

NDC 53002-0600-1 [53002060001]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:079fdfb4-8007-4f5a-a8fa-4b72c3748632
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" or generic name "Ondansetron Hydrochloride"

    NDCBrand NameGeneric Name
    0143-2422OndansetronOndansetron hydrochloride
    0143-2423OndansetronOndansetron hydrochloride
    0143-2424OndansetronOndansetron
    0143-9890OndansetronOndansetron
    0143-9891OndansetronOndansetron
    0179-0099ondansetronondansetron hydrochloride
    0179-0100ondansetronondansetron hydrochloride
    0378-0315Ondansetronondansetron
    0378-0344Ondansetronondansetron
    0378-0374Ondansetronondansetron
    0378-7732OndansetronOndansetron
    0378-7734OndansetronOndansetron
    0404-9930ONDANSETRONONDANSETRON
    67877-169ondansetronondansetron
    67877-170ondansetronondansetron
    0409-4755OndansetronOndansetron
    0409-4759OndansetronOndansetron
    68001-247OndansetronOndansetron
    68001-246OndansetronOndansetron
    68071-1547OndansetronOndansetron
    68071-1804OndansetronOndansetron
    68071-1658OndansetronOndansetron
    68071-1730OndansetronOndansetron
    68071-1904OndansetronOndansetron
    68071-1649OndansetronOndansetron
    68071-1987OndansetronOndansetron
    68071-1968ONDANSETRONONDANSETRON
    68071-1977ONDANSETRONONDANSETRON
    68071-3028OndansetronOndansetron
    68071-3195OndansetronOndansetron
    68071-3268OndansetronOndansetron
    68071-4190OndansetronOndansetron
    68071-3275OndansetronOndansetron
    68071-4191ONDANSETRONONDANSETRON
    68071-4513OndansetronOndansetron
    68071-4426OndansetronOndansetron
    68071-4115OndansetronOndansetron
    68071-4566OndansetronOndansetron
    68071-4570OndansetronOndansetron
    68071-4409OndansetronOndansetron
    68071-4594OndansetronOndansetron
    68071-4810OndansetronOndansetron
    68071-4717OndansetronOndansetron
    68083-114OndansetronOndansetron
    68083-113OndansetronOndansetron
    68071-4529ondansetronondansetron
    68258-7068OndansetronOndansetron
    68462-105OndansetronOndansetron
    68462-157OndansetronOndansetron
    68462-158OndansetronOndansetron
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