NDC 35356-853

Ondansetron

Ondansetron

Ondansetron is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Ondansetron Hydrochloride.

Product ID35356-853_92a82257-b1a4-4250-9997-59ff814a4d3f
NDC35356-853
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-07-27
Marketing CategoryANDA / ANDA
Application NumberANDA077851
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameONDANSETRON HYDROCHLORIDE
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 35356-853-10

10 TABLET, FILM COATED in 1 BOTTLE (35356-853-10)
Marketing Start Date2007-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-853-09 [35356085309]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-11
Marketing End Date2019-06-30

NDC 35356-853-10 [35356085310]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-30
Marketing End Date2019-06-30

NDC 35356-853-06 [35356085306]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-11
Marketing End Date2019-06-30

NDC 35356-853-20 [35356085320]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-30
Marketing End Date2019-06-30

NDC 35356-853-30 [35356085330]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-30
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 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
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