Ondansetron

Product NDC
63187-266
11-digit product format
631870266
Labeler code
63187
Product ID
63187-266_f02e87c2-4b3e-46d7-8afd-c321c83f90ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
Substance
ONDANSETRON
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
4AF302ESOSONDANSETRON99614-02-5ONDANSETRON

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63187-266-106318702661010 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-266-10) 2014-11-03NoNoHistorical
63187-266-156318702661515 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-266-15) 2018-06-01NoNoHistorical
63187-266-206318702662020 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-266-20) 2017-02-01NoNoHistorical
63187-266-306318702663030 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-266-30) 2014-11-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ondansetron Orally Disintegrating Tablets, USP Rx onlyProficient Rx LP2020-01-01HUMAN PRESCRIPTION DRUG LABEL6