FDA.reportPublic FDA data

ONDANSETRON

Product NDC
61919-565
11-digit product format
619190565
Labeler code
61919
Product ID
61919-565_4b32211f-c9b5-5ea2-e063-6394a90a2834
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078539
Marketing category
ANDA
Marketing start
2019-08-22
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
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 HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052

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
61919-565-302025-05-08C16284748780-1ba0f9c33-2806-a910-e053-dadaa90a0b85ONDANSETRON 4mg
61919-565-122025-01-30C16284748780-12cef2736-aebf-d83d-e063-dadaa90ab31fONDANSETRON 4mg
61919-565-602025-01-30C16284748780-12cef2736-aebf-d83d-e063-dadaa90ab31fONDANSETRON 4mg
61919-565-302021-01-29C16284748780-1ba0f9c33-2806-a910-e053-dadaa90a0b85ONDANSETRON 4mg
61919-565-902021-01-29C16284748780-1ba0f9c33-321f-a910-e053-dadaa90a0b85ONDANSETRON 4mg
61919-565-102020-01-31C16284748780-19d75b9cf-e06f-f424-e053-dadaa90a57ceONDANSETRON 4mg
61919-565-202020-01-31C16284748780-19d75b9cf-e06f-f424-e053-dadaa90a57ceONDANSETRON 4mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-565-12ONDANSETRON12 in 1 BOTTLETABLET, FILM COATED124
61919-565-60ONDANSETRON60 in 1 BOTTLETABLET, FILM COATED604
61919-565-30ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED303
61919-565-45ONDANSETRON45 in 1 BOTTLETABLET, FILM COATED453
61919-565-10ONDANSETRON1 in 1 BOTTLETABLET, FILM COATED12
61919-565-20ONDANSETRON20 in 1 BOTTLETABLET, FILM COATED202
61919-565-90ONDANSETRON90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-565-10EA - Each61919-5659bd03660-b40a-46ee-83ca-a0b73d6d14ce12018-10-11
61919-565-12EA - Each61919-56597841314-e38b-412e-9068-e0f981a04e6012019-10-07
61919-565-20EA - Each61919-565d8abd4c5-6d43-42e5-bfbd-135a1cadfa7b12016-09-02
61919-565-30EA - Each61919-5657a028dbe-e043-4790-a6dc-d8f0b6e5202912019-09-05
61919-565-45EA - Each61919-565e7c19861-f5ce-48f5-8ec8-40610b31527112026-03-17
61919-565-60EA - Each61919-565bf944937-b4ee-47ec-a850-24c647562d3e12023-05-05
61919-565-90EA - Each61919-565358c8ae6-4ba5-4bd9-b3f6-998d3350fd3812019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-565ONDANSETRON TABLET, FILM COATED [DIRECT_RX]4Current NDC, Legacy NDC, 2 package rows20230422_91e36582-758e-49d2-e053-2995a90a6f7b.zip
61919-565ONDANSETRON TABLET, FILM COATED [DIRECT RX]2Current NDC, Legacy NDC, 2 package rows20180912_2ebdb67e-d584-0f7b-e054-00144ff8d46c.zip
61919-565ONDANSETRON TABLET, FILM COATED [DIRECT_RX]2Current NDC, Legacy NDC, 2 package rows20250509_90b73778-2ab5-5460-e053-2a95a90abbc1.zip
61919-565ONDANSETRON TABLET, FILM COATED [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190823_90b77a2b-6ac8-b68b-e053-2a95a90af009.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN91e36582-758e-49d2-e053-2995a90a6f7b4
198052ondansetron 4 MG Oral TabletSCD91e36582-758e-49d2-e053-2995a90a6f7b4
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY91e36582-758e-49d2-e053-2995a90a6f7b4
198052ondansetron HCl 4 MG Oral TabletPSN90b73778-2ab5-5460-e053-2a95a90abbc13
198052ondansetron 4 MG Oral TabletSCD90b73778-2ab5-5460-e053-2a95a90abbc13
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY90b73778-2ab5-5460-e053-2a95a90abbc13
198052ondansetron HCl 4 MG Oral TabletPSN2ebdb67e-d584-0f7b-e054-00144ff8d46c2
198052ondansetron 4 MG Oral TabletSCD2ebdb67e-d584-0f7b-e054-00144ff8d46c2
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY2ebdb67e-d584-0f7b-e054-00144ff8d46c2
198052ondansetron HCl 4 MG Oral TabletPSN90b77a2b-6ac8-b68b-e053-2a95a90af0091
198052ondansetron 4 MG Oral TabletSCD90b77a2b-6ac8-b68b-e053-2a95a90af0091
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY90b77a2b-6ac8-b68b-e053-2a95a90af0091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-565-10619190565101 in 1 BOTTLEHistorical
61919-565-126191905651212 TABLET, FILM COATED in 1 BOTTLE (61919-565-12) 2019-09-060000-00-00NoNoCurrent
61919-565-206191905652020 in 1 BOTTLEHistorical
61919-565-306191905653030 TABLET, FILM COATED in 1 BOTTLE (61919-565-30) 2019-08-22NoNoHistorical
61919-565-456191905654545 TABLET, FILM COATED in 1 BOTTLE (61919-565-45) 2019-08-22NoNoHistorical
61919-565-606191905656060 in 1 BOTTLEHistorical
61919-565-906191905659090 in 1 BOTTLEHistorical