NDC 63629-7951

Ondansetron

Ondansetron

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

Product ID63629-7951_511cf73c-a2d6-474c-b740-98f1d05eb3b2
NDC63629-7951
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 NameBryant Ranch Prepack
Substance NameONDANSETRON
Active Ingredient Strength4 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63629-7951-1

15 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-7951-1)
Marketing Start Date2019-03-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-7951-1 [63629795101]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090469
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-20

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON4 mg/1

OpenFDA Data

SPL SET ID:511cf73c-a2d6-474c-b740-98f1d05eb3b2
Manufacturer
UNII

Pharmacological Class

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