NDC 61919-565

ONDANSETRON

Ondansetron

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

Product ID61919-565_75b0c827-08e6-e445-e053-2991aa0a2141
NDC61919-565
Product TypeHuman Prescription Drug
Proprietary NameONDANSETRON
Generic NameOndansetron
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-03-23
Marketing CategoryANDA / ANDA
Application NumberANDA078539
Labeler NameDIRECT RX
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 61919-565-12

12 TABLET, FILM COATED in 1 BOTTLE (61919-565-12)
Marketing Start Date2019-09-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-565-12 [61919056512]

ONDANSETRON TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-06

NDC 61919-565-20 [61919056520]

ONDANSETRON TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-23
Inactivation Date2020-01-31

NDC 61919-565-10 [61919056510]

ONDANSETRON TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-12
Inactivation Date2020-01-31

NDC 61919-565-90 [61919056590]

ONDANSETRON TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-22

NDC 61919-565-30 [61919056530]

ONDANSETRON TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-22

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:2ebdb67e-d584-0f7b-e054-00144ff8d46c
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" 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.