FDA.reportPublic FDA data

Ondansetron

Product NDC
71335-3073
11-digit product format
713353073
Labeler code
71335
Product ID
71335-3073_06b5802b-105f-4bc8-92de-447aeea9ad2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui312087

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
71335-3073-1Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING301
71335-3073-2Ondansetron10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING101
71335-3073-3Ondansetron9 in 1 BOTTLETABLET, ORALLY DISINTEGRATING91
71335-3073-4Ondansetron5 in 1 BOTTLETABLET, ORALLY DISINTEGRATING51
71335-3073-5Ondansetron3 in 1 BOTTLETABLET, ORALLY DISINTEGRATING31
71335-3073-6Ondansetron6 in 1 BOTTLETABLET, ORALLY DISINTEGRATING61
71335-3073-7Ondansetron12 in 1 BOTTLETABLET, ORALLY DISINTEGRATING121
71335-3073-8Ondansetron4 in 1 BOTTLETABLET, ORALLY DISINTEGRATING41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN77397df5-5a4f-41b2-98bc-f817a1e497fc1
312087ondansetron 8 MG Disintegrating Oral TabletSCD77397df5-5a4f-41b2-98bc-f817a1e497fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3073-17133530730130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-1) 2026-02-09NoNoHistorical
71335-3073-27133530730210 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-2) 2026-02-09NoNoHistorical
71335-3073-3713353073039 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-3) 2026-02-09NoNoHistorical
71335-3073-4713353073045 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-4) 2026-02-09NoNoHistorical
71335-3073-5713353073053 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-5) 2026-02-09NoNoHistorical
71335-3073-6713353073066 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-6) 2026-02-09NoNoHistorical
71335-3073-77133530730712 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-7) 2026-02-09NoNoHistorical
71335-3073-8713353073084 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-3073-8) 2026-02-09NoNoHistorical