FDA.reportPublic FDA data

Ondansetron

Product NDC
51407-004
11-digit product format
514070004
Labeler code
51407
Product ID
51407-004_49684d71-7db8-3561-e063-6394a90a2def
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

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
51407-004-05Ondansetron500 in 1 BOTTLETABLET5003
51407-004-30Ondansetron30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-004ONDANSETRON TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 2 package rows20250116_2b9ea1fc-59a4-8189-e063-6394a90a9ae6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN2b9ea1fc-59a4-8189-e063-6394a90a9ae63
312086ondansetron HCl 8 MG Oral TabletPSN2b9ea1fc-59a4-8189-e063-6394a90a9ae63
198052ondansetron 4 MG Oral TabletSCD2b9ea1fc-59a4-8189-e063-6394a90a9ae63
312086ondansetron 8 MG Oral TabletSCD2b9ea1fc-59a4-8189-e063-6394a90a9ae63
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY2b9ea1fc-59a4-8189-e063-6394a90a9ae63
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2b9ea1fc-59a4-8189-e063-6394a90a9ae63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-004-0551407000405500 TABLET in 1 BOTTLE (51407-004-05) 500 tablet2025-01-07NoNoCurrent
51407-004-305140700043030 TABLET in 1 BOTTLE (51407-004-30) 30 tablet2025-01-08NoNoCurrent