NDC 0378-0315

Ondansetron

Ondansetron

Ondansetron is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc. The primary component is Ondansetron Hyd.

Product ID0378-0315_3068e5cf-4eb6-4bef-b433-5467e899c69b
NDC0378-0315
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA076930
Labeler NameMylan Pharmaceuticals Inc
Substance NameONDANSETRON HYD
Active Ingredient Strength4 mg/1
Pharm ClassesSerotonin 3 Rec
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-0315-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0315-01)
Marketing Start Date2007-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0315-93 [00378031593]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076930
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Marketing End Date2020-01-31

NDC 0378-0315-53 [00378031553]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076930
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Marketing End Date2011-08-07

NDC 0378-0315-01 [00378031501]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076930
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-25
Marketing End Date2014-10-15

NDC 0378-0315-05 [00378031505]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076930
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-25
Marketing End Date2014-10-15

Drug Details

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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