NDC 55700-627

Ondansetron Hydrochloride

Ondansetron Hydrochloride

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

Product ID55700-627_0649ba25-e34d-4877-9acb-563331e0d685
NDC55700-627
Product TypeHuman Prescription Drug
Proprietary NameOndansetron Hydrochloride
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA078539
Labeler NameLake Erie Medical DBA Qua
Substance NameONDANSETRON HYD
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Rec
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55700-627-10

10 TABLET, FILM COATED in 1 BOTTLE (55700-627-10)
Marketing Start Date2018-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-627-12 [55700062712]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-18

NDC 55700-627-30 [55700062730]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-18

NDC 55700-627-20 [55700062720]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-18

NDC 55700-627-10 [55700062710]

Ondansetron Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078539
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-18

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "Ondansetron Hydrochloride" or generic name "Ondansetron Hydrochloride"

NDCBrand NameGeneric Name
0054-0064Ondansetron HydrochlorideOndansetron Hydrochloride
0179-0247Ondansetron HydrochlorideOndansetron Hydrochloride
0179-0248Ondansetron HydrochlorideOndansetron Hydrochloride
0527-1726Ondansetron HydrochlorideOndansetron Hydrochloride
0615-8185ondansetron hydrochlorideondansetron hydrochloride
0904-6551ondansetron hydrochlorideondansetron hydrochloride
0904-6552ondansetron hydrochlorideondansetron hydrochloride
10544-575Ondansetron HydrochlorideOndansetron Hydrochloride
21695-834ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
21695-835ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
68071-1816Ondansetron HydrochlorideOndansetron Hydrochloride
68071-2147Ondansetron HydrochlorideOndansetron Hydrochloride
68071-4206Ondansetron HydrochlorideOndansetron Hydrochloride
68071-4208Ondansetron HydrochlorideOndansetron Hydrochloride
68071-4328Ondansetron HydrochlorideOndansetron Hydrochloride
68071-4705Ondansetron HydrochlorideOndansetron Hydrochloride
68084-220Ondansetron HydrochlorideOndansetron Hydrochloride
68084-221Ondansetron HydrochlorideOndansetron Hydrochloride
68151-1668Ondansetron HydrochlorideOndansetron Hydrochloride
68094-763Ondansetron HydrochlorideOndansetron Hydrochloride
68788-9368Ondansetron HydrochlorideOndansetron Hydrochloride
68788-9402Ondansetron HydrochlorideOndansetron Hydrochloride
68788-9893ondansetron hydrochlorideondansetron hydrochloride
68788-9892ondansetron hydrochlorideondansetron hydrochloride
70518-1394Ondansetron HydrochlorideOndansetron Hydrochloride
70518-1042ondansetron hydrochlorideondansetron hydrochloride
70518-1585Ondansetron HydrochlorideOndansetron Hydrochloride
70934-148Ondansetron HydrochlorideOndansetron Hydrochloride
71335-0205Ondansetron HydrochlorideOndansetron Hydrochloride
71610-119Ondansetron HydrochlorideOndansetron Hydrochloride
71872-7138Ondansetron HydrochlorideOndansetron Hydrochloride
23155-196Ondansetron HydrochlorideOndansetron Hydrochloride
23155-168Ondansetron HydrochlorideOndansetron Hydrochloride
23155-377Ondansetron HydrochlorideOndansetron Hydrochloride
23155-378Ondansetron HydrochlorideOndansetron Hydrochloride
33261-417Ondansetron HydrochlorideOndansetron Hydrochloride
35356-679ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
33261-745Ondansetron HydrochlorideOndansetron Hydrochloride
36000-012ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
36000-013ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDE
42708-044Ondansetron HydrochlorideOndansetron Hydrochloride
42708-059Ondansetron HydrochlorideOndansetron Hydrochloride
43063-792Ondansetron HydrochlorideOndansetron Hydrochloride
45865-509Ondansetron HydrochlorideOndansetron Hydrochloride
50090-3185Ondansetron HydrochlorideOndansetron Hydrochloride
50090-3178Ondansetron HydrochlorideOndansetron Hydrochloride
50436-0131ondansetron hydrochlorideondansetron hydrochloride
50436-1880Ondansetron HydrochlorideOndansetron Hydrochloride
50268-621Ondansetron HydrochlorideOndansetron Hydrochloride
50268-622Ondansetron HydrochlorideOndansetron Hydrochloride
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