NDC 54348-819

Ondansetron

Ondansetron

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

Product ID54348-819_90910cd1-e114-6803-e053-2a95a90a730b
NDC54348-819
Product TypeHuman Prescription Drug
Proprietary NameOndansetron
Generic NameOndansetron
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-10
Marketing CategoryANDA / ANDA
Application NumberANDA078539
Labeler NamePharmPak, Inc.
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 54348-819-00

1 BOTTLE in 1 BOX (54348-819-00) > 1 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2019-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-819-08 [54348081908]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-819-00 [54348081900]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-819-02 [54348081902]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-819-04 [54348081904]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-819-06 [54348081906]

Ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:8e289184-6046-4b55-97d2-cb276d5782d5
Manufacturer
UNII

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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