Ondansetron Hydrochloride

Product NDC
68071-1742
11-digit product format
680711742
Labeler code
68071
Product ID
68071-1742_2d82d4f9-ca65-ed20-e063-6294a90aacf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
NMH84OZK2BONDANSETRON HYDROCHLORIDE103639-04-9ONDANSETRON HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-1742-36807117420330 TABLET, FILM COATED in 1 BOTTLE (68071-1742-3) 2023-04-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ondansetron HydrochlorideNuCare Pharmaceuticals,Inc.2025-02-06HUMAN PRESCRIPTION DRUG LABEL2