FDA.reportPublic FDA data

ONDANSETRON

Product NDC
63629-4306
11-digit product format
636294306
Labeler code
63629
Product ID
63629-4306_d33adc9e-77b0-4e55-90ab-0944938ccf1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077557
Marketing category
ANDA
Marketing start
2007-08-02
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui198052, 312087

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4306-02020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-12020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-22020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-32020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-42020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-52020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-62020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-72020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-82020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-92020-10-16C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-02020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-12020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-22020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-32020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-42020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-52020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-62020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-72020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-82020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
63629-4306-92020-01-31C16284748780-19d75b9cf-dca6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON HYDROCHLORIDE tablets, for oral use ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4306-0ONDANSETRON3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING313
63629-4306-1ONDANSETRON30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING3013
63629-4306-2ONDANSETRON10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1013
63629-4306-3ONDANSETRON5 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING513
63629-4306-4ONDANSETRON4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING413
63629-4306-5ONDANSETRON6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING613
63629-4306-6ONDANSETRON14 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1413
63629-4306-7ONDANSETRON60 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING6013
63629-4306-8ONDANSETRON12 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1213
63629-4306-9ONDANSETRON90 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4306-1EA - Each63629-43063b19adee-ad7a-403c-9184-661a18d95a6d12012-07-24
63629-4306-2EA - Each63629-43065588a318-3773-41e3-a019-d1a05501deac12012-07-24
63629-4306-3EA - Each63629-430602b79ace-a07c-4f84-a443-172291719d3812012-07-24
63629-4306-4EA - Each63629-4306cb3da74d-07dd-4f2f-b51d-1ce3d0520c6612013-02-13
63629-4306-5EA - Each63629-4306d6b93a17-f157-4669-a854-7df64fb0a27b12013-02-13
63629-4306-6EA - Each63629-43067b038889-8ab6-4f32-bc50-36a232fc322612013-02-13
63629-4306-7EA - Each63629-4306f50e7360-f2bf-4e8c-8c4b-cbedfff8911f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4306ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 10 package rows20240602_384a5cfb-05dd-2b79-73f4-a01a47a9eb3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13
198052ondansetron HCl 4 MG Oral TabletPSN384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13
198052ondansetron 4 MG Oral TabletSCD384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13
312087ondansetron 8 MG Disintegrating Oral TabletSCD384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY384a5cfb-05dd-2b79-73f4-a01a47a9eb3e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4306-0636294306003 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-0) 2010-08-200000-00-00NoNoCurrent
63629-4306-16362943060130 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-1) 2013-08-190000-00-00NoNoCurrent
63629-4306-26362943060210 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-2) 2013-08-190000-00-00NoNoCurrent
63629-4306-3636294306035 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-3) 2013-08-190000-00-00NoNoCurrent
63629-4306-4636294306044 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-4) 2010-08-200000-00-00NoNoCurrent
63629-4306-5636294306056 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-5) 2010-08-200000-00-00NoNoCurrent
63629-4306-66362943060614 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-6) 2010-08-200000-00-00NoNoCurrent
63629-4306-76362943060760 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-7) 2010-08-200000-00-00NoNoCurrent
63629-4306-86362943060812 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-8) 2010-08-200000-00-00NoNoCurrent
63629-4306-96362943060990 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-9) 2010-08-200000-00-00NoNoCurrent