FDA.reportPublic FDA data

ONDANSETRON

Product NDC
63187-065
11-digit product format
631870065
Labeler code
63187
Product ID
63187-065_dcd5d6d3-2419-467f-91c2-50586e9ca5cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-06-25
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

Additional Listing Data#

Finished product
Yes
Brand name base
ONDANSETRON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052, 312086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-065-10ONDANSETRON10 in 1 BOTTLETABLET, FILM COATED104
63187-065-15ONDANSETRON15 in 1 BOTTLETABLET, FILM COATED154
63187-065-20ONDANSETRON20 in 1 BOTTLETABLET, FILM COATED204
63187-065-30ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED304
63187-065-60ONDANSETRON60 in 1 BOTTLETABLET, FILM COATED604
63187-065-90ONDANSETRON90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-065ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20191122_41c0dc3d-a616-425e-9073-625a0cb692c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN41c0dc3d-a616-425e-9073-625a0cb692c44
312086ondansetron HCl 8 MG Oral TabletPSN41c0dc3d-a616-425e-9073-625a0cb692c44
198052ondansetron 4 MG Oral TabletSCD41c0dc3d-a616-425e-9073-625a0cb692c44
312086ondansetron 8 MG Oral TabletSCD41c0dc3d-a616-425e-9073-625a0cb692c44
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY41c0dc3d-a616-425e-9073-625a0cb692c44
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY41c0dc3d-a616-425e-9073-625a0cb692c44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-065-106318700651010 TABLET, FILM COATED in 1 BOTTLE (63187-065-10) 2014-04-010000-00-00NoNoCurrent
63187-065-156318700651515 TABLET, FILM COATED in 1 BOTTLE (63187-065-15) 2014-04-010000-00-00NoNoCurrent
63187-065-206318700652020 TABLET, FILM COATED in 1 BOTTLE (63187-065-20) 2014-04-010000-00-00NoNoCurrent
63187-065-306318700653030 TABLET, FILM COATED in 1 BOTTLE (63187-065-30) 2014-04-010000-00-00NoNoCurrent
63187-065-606318700656060 TABLET, FILM COATED in 1 BOTTLE (63187-065-60) 2014-04-010000-00-00NoNoCurrent
63187-065-906318700659090 TABLET, FILM COATED in 1 BOTTLE (63187-065-90) 2014-04-010000-00-00NoNoCurrent