FDA.reportPublic FDA data

Ondansetron

Product NDC
71335-0650
11-digit product format
713350650
Labeler code
71335
Product ID
71335-0650_e5cd8042-5934-4ebf-98f2-90e3d5b48beb
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
4 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
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0650-02024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-12024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-22024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-32024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-42024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-52024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-62024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-72024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-82024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-92024-04-17C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-02024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-12024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-22024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-32024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-42024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-52024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-62024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-72024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-82024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
71335-0650-92024-01-30C16284748780-11030e365-10f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0650-0Ondansetron90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING907
71335-0650-1Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING307
71335-0650-2Ondansetron20 in 1 BOTTLETABLET, ORALLY DISINTEGRATING207
71335-0650-3Ondansetron10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING107
71335-0650-4Ondansetron6 in 1 BOTTLETABLET, ORALLY DISINTEGRATING67
71335-0650-5Ondansetron60 in 1 BOTTLETABLET, ORALLY DISINTEGRATING607
71335-0650-6Ondansetron9 in 1 BOTTLETABLET, ORALLY DISINTEGRATING97
71335-0650-7Ondansetron5 in 1 BOTTLETABLET, ORALLY DISINTEGRATING57
71335-0650-8Ondansetron15 in 1 BOTTLETABLET, ORALLY DISINTEGRATING157
71335-0650-9Ondansetron3 in 1 BOTTLETABLET, ORALLY DISINTEGRATING37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0650-1EA - Each71335-065000f932eb-1212-4cb6-874e-115d14ab486b12019-09-05
71335-0650-2EA - Each71335-0650dd30ac2d-72c0-4dd5-8689-de6466f5306212019-10-07
71335-0650-3EA - Each71335-0650ec81bc42-6750-4680-a26c-80c485ea994212019-09-05
71335-0650-4EA - Each71335-06502d7d5526-85b5-48b3-9603-d9921db88e0a12019-09-05
71335-0650-5EA - Each71335-065026e57605-8db8-4a61-9a5f-9ebfe775c45712019-05-02
71335-0650-6EA - Each71335-0650d43a2f8f-4ac0-43bc-a6a0-d17caeac8e8412019-09-05
71335-0650-7EA - Each71335-0650916284c8-7247-4dd5-8daa-d6870f4ded2412019-09-05
71335-0650-8EA - Each71335-0650566b54c2-2b9e-4901-ad21-1a21ef99f43612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0650ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20240418_e8d775b6-478c-499e-82be-bfdf006445e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNe8d775b6-478c-499e-82be-bfdf006445e37
104894ondansetron 4 MG Disintegrating Oral TabletSCDe8d775b6-478c-499e-82be-bfdf006445e37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0650-07133506500090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-0) 2024-04-030000-00-00NoNoCurrent
71335-0650-17133506500130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-1) 2018-10-040000-00-00NoNoCurrent
71335-0650-27133506500220 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-2) 2018-10-230000-00-00NoNoCurrent
71335-0650-37133506500310 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-3) 2018-10-030000-00-00NoNoCurrent
71335-0650-4713350650046 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-4) 2019-02-120000-00-00NoNoCurrent
71335-0650-57133506500560 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-5) 2019-01-100000-00-00NoNoCurrent
71335-0650-6713350650069 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-6) 2019-05-240000-00-00NoNoCurrent
71335-0650-7713350650075 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-7) 2018-03-280000-00-00NoNoCurrent
71335-0650-87133506500815 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-8) 2018-10-290000-00-00NoNoCurrent
71335-0650-9713350650093 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-0650-9) 2020-11-050000-00-00NoNoCurrent