FDA.reportPublic FDA data

ONDANSETRON

Product NDC
55111-153
11-digit product format
551110153
Labeler code
55111
Product ID
55111-153_b5be4b6c-42cd-c9b3-a0df-e15c946ec89b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076183
Marketing category
ANDA
Marketing start
2006-12-26
Substance
ONDANSETRON HYDROCHLORIDE
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
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052, 312084, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55111-153-012020-05-14C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-153-052020-05-14C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-153-132020-05-14C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-153-302020-05-14C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-153-782020-05-14C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-153-012020-01-31C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-153-052020-01-31C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-153-132020-01-31C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-153-302020-01-31C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
55111-153-782020-01-31C16284748780-19d75b9d0-bd73-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-153-01ONDANSETRON100 in 1 BOTTLETABLET, FILM COATED10017
55111-153-05ONDANSETRON500 in 1 BOTTLETABLET, FILM COATED50017
55111-153-13ONDANSETRON1 in 1 DOSE PACKTABLET, FILM COATED117
55111-153-13ONDANSETRON3 in 1 BOXTABLET, FILM COATED317
55111-153-30ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED3017
55111-153-78ONDANSETRON10 in 1 DOSE PACKTABLET, FILM COATED1017
55111-153-78ONDANSETRON10 in 1 BOXTABLET, FILM COATED1017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-153-13EA - Each55111-153e4dc83d8-ff9b-4ce3-a56f-ddfdb11ea6b112012-07-24
55111-153-30EA - Each55111-153b14a09f3-7835-4532-886a-3346fb7d1c9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
magnesium stearateINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-153ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]16Current NDC, Legacy NDC, 7 package rows20250315_162f2088-9fb1-47e7-b88c-45104be7e7bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN00327696-c496-4c83-a63e-9e29fd6246d422
198052ondansetron 4 MG Oral TabletSCD00327696-c496-4c83-a63e-9e29fd6246d422
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY00327696-c496-4c83-a63e-9e29fd6246d422
312084ondansetron 24 MG Oral TabletPSN162f2088-9fb1-47e7-b88c-45104be7e7bb17
198052ondansetron HCl 4 MG Oral TabletPSN162f2088-9fb1-47e7-b88c-45104be7e7bb17
312086ondansetron HCl 8 MG Oral TabletPSN162f2088-9fb1-47e7-b88c-45104be7e7bb17
312084ondansetron 24 MG Oral TabletSCD162f2088-9fb1-47e7-b88c-45104be7e7bb17
198052ondansetron 4 MG Oral TabletSCD162f2088-9fb1-47e7-b88c-45104be7e7bb17
312086ondansetron 8 MG Oral TabletSCD162f2088-9fb1-47e7-b88c-45104be7e7bb17
312084ondansetron 24 MG (ondansetron hydrochloride dihydrate 30 MG) Oral TabletSY162f2088-9fb1-47e7-b88c-45104be7e7bb17
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY162f2088-9fb1-47e7-b88c-45104be7e7bb17
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY162f2088-9fb1-47e7-b88c-45104be7e7bb17
198052ondansetron HCl 4 MG Oral TabletPSNa29b5c18-9884-4c88-8827-65d9ad5f69f610
312086ondansetron HCl 8 MG Oral TabletPSNa29b5c18-9884-4c88-8827-65d9ad5f69f610
198052ondansetron 4 MG Oral TabletSCDa29b5c18-9884-4c88-8827-65d9ad5f69f610
312086ondansetron 8 MG Oral TabletSCDa29b5c18-9884-4c88-8827-65d9ad5f69f610
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYa29b5c18-9884-4c88-8827-65d9ad5f69f610
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYa29b5c18-9884-4c88-8827-65d9ad5f69f610
198052ondansetron HCl 4 MG Oral TabletPSN4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf1
198052ondansetron 4 MG Oral TabletSCD4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf1
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-153-0155111015301100 TABLET, FILM COATED in 1 BOTTLE (55111-153-01) 2006-12-260000-00-00NoNoCurrent
55111-153-0555111015305500 TABLET, FILM COATED in 1 BOTTLE (55111-153-05) 2006-12-260000-00-00NoNoCurrent
55111-153-13551110153133 DOSE PACK in 1 BOX (55111-153-13) / 1 TABLET, FILM COATED in 1 DOSE PACK3 dose pack2006-12-260000-00-00NoNoCurrent
55111-153-305511101533030 TABLET, FILM COATED in 1 BOTTLE (55111-153-30) 2006-12-260000-00-00NoNoCurrent
55111-153-785511101537810 DOSE PACK in 1 BOX (55111-153-78) / 10 TABLET, FILM COATED in 1 DOSE PACK10 dose pack2006-12-260000-00-00NoNoCurrent