NDC 68001-247

Ondansetron

Ondansetron

Ondansetron is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Bluepoint Laboratories. The primary component is Ondansetron.

Product ID68001-247_492a9614-506e-47fa-a782-e9048d6fff44
NDC68001-247
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2014-03-13
Marketing CategoryANDA / ANDA
Application NumberANDA078152
Labeler NameBluePoint Laboratories
Substance NameONDANSETRON
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68001-247-04

30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68001-247-04)
Marketing Start Date2018-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68001-247-01 [68001024701]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-03-13
Marketing End Date2018-02-27

NDC 68001-247-04 [68001024704]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-13

NDC 68001-247-55 [68001024755]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-13
Marketing End Date2019-03-13

NDC 68001-247-16 [68001024716]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-03-13

NDC 68001-247-17 [68001024717]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-03-13

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON8 mg/1

OpenFDA Data

SPL SET ID:ed1132ec-c2cd-4646-b69d-26663bb937a4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 104894
  • 312087
  • UPC Code
  • 0368001247047
  • 0368001247559
  • 0368001246040
  • Pharmacological Class

    • Serotonin 3 Receptor Antagonists [MoA]
    • Serotonin-3 Receptor Antagonist [EPC]

    Medicade Reported Pricing

    68001024717 ONDANSETRON ODT 8 MG TABLET

    Pricing Unit: EA | Drug Type:

    68001024716 ONDANSETRON ODT 8 MG TABLET

    Pricing Unit: EA | Drug Type:

    68001024704 ONDANSETRON ODT 8 MG TABLET

    Pricing Unit: EA | Drug Type:

    68001024701 ONDANSETRON ODT 8 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Ondansetron" or generic name "Ondansetron"

    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
    0409-1120OndansetronONDANSETRON
    0409-4755OndansetronONDANSETRON
    0409-4759OndansetronONDANSETRON
    0641-6078OndansetronOndansetron
    0641-6079OndansetronOndansetron
    0641-6080OndansetronOndansetron
    67877-169ondansetronondansetron
    67877-170ondansetronondansetron
    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

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