NDC 0781-5239

Ondansetron

Ondansetron

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

Product ID0781-5239_0ab801d6-8deb-43c6-ac70-9f27920d1089
NDC0781-5239
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2007-08-13
Marketing CategoryANDA / ANDA
Application NumberANDA078050
Labeler NameSandoz Inc
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 0781-5239-80

1 BLISTER PACK in 1 CARTON (0781-5239-80) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5239-06)
Marketing Start Date2007-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5239-06 [00781523906]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-19
Marketing End Date2020-12-31

NDC 0781-5239-80 [00781523980]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-13
Marketing End Date2020-10-31

NDC 0781-5239-64 [00781523964]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-13
Marketing End Date2020-12-31

NDC 0781-5239-01 [00781523901]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-08-13
Marketing End Date2007-08-13

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON8 mg/1

OpenFDA Data

SPL SET ID:5fad6aba-321a-4ed3-8d8e-2806aaeb2ff7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 104894
  • 312087
    • UPC Code
  • 0307815239800
  • 0307815238643

    • Pharmacological Class

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

    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
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