NDC 63187-526

Ondansetron

Ondansetron

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

Product ID63187-526_0536f0ae-6ce8-4b92-b8e1-026665b5d6fd
NDC63187-526
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2010-04-12
Marketing CategoryANDA / ANDA
Application NumberANDA090469
Labeler NameProficient Rx LP
Substance NameONDANSETRON
Active Ingredient Strength4 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63187-526-03

3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-03)
Marketing Start Date2019-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-526-03 [63187052603]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-01

NDC 63187-526-06 [63187052606]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-01

NDC 63187-526-30 [63187052630]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-03

NDC 63187-526-20 [63187052620]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-01

NDC 63187-526-05 [63187052605]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-01

NDC 63187-526-15 [63187052615]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090469
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-01

NDC 63187-526-04 [63187052604]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-25

NDC 63187-526-10 [63187052610]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090469
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-03

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON4 mg/1

OpenFDA Data

SPL SET ID:f6f2e4ee-dc8b-478d-b0d6-d192119691b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 104894

    • 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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