NDC 71335-0549

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 ID71335-0549_61b62426-786f-4d6a-93b4-6230b3f26ab5
NDC71335-0549
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 NameBryant Ranch Prepack
Substance NameONDANSETRON
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71335-0549-0

3 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0549-0)
Marketing Start Date2010-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0549-1 [71335054901]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

NDC 71335-0549-8 [71335054908]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

NDC 71335-0549-9 [71335054909]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

NDC 71335-0549-3 [71335054903]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

NDC 71335-0549-4 [71335054904]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

NDC 71335-0549-0 [71335054900]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

NDC 71335-0549-2 [71335054902]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

NDC 71335-0549-6 [71335054906]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

NDC 71335-0549-5 [71335054905]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

NDC 71335-0549-7 [71335054907]

Ondansetron TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA078050
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-20

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON8 mg/1

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.