Ondansetron

Product NDC
70518-4588
11-digit product format
705184588
Labeler code
70518
Product ID
70518-4588_4d73f057-8b15-e4d0-e063-6394a90a5863
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077851
Marketing category
ANDA
Marketing start
2026-03-20
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
NMH84OZK2BONDANSETRON HYDROCHLORIDE103639-04-9ONDANSETRON HYDROCHLORIDE
4AF302ESOSONDANSETRON99614-02-5Ondansetron

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4588-07051845880030 TABLET in 1 BLISTER PACK (70518-4588-0) 30 tablet2026-03-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OndansetronREMEDYREPACK INC.2026-03-20HUMAN PRESCRIPTION DRUG LABEL1