FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
71335-1855
11-digit product format
713351855
Labeler code
71335
Product ID
71335-1855_9a6c7ef2-c4e5-4846-b234-dec3c4a0c847
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
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 Hydrochloride
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1855-0Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60105
71335-1855-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED10105
71335-1855-2Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED3105
71335-1855-3Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30105
71335-1855-4Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED15105
71335-1855-5Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED6105
71335-1855-6Ondansetron Hydrochloride4 in 1 BOTTLETABLET, FILM COATED4105
71335-1855-7Ondansetron Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90105
71335-1855-8Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED12105
71335-1855-9Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED20105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1855-0EA - Each71335-1855f20c56f7-bfe7-47a0-ae29-8e6b36b1bd1412023-10-16
71335-1855-3EA - Each71335-1855f0b49719-a63a-42c3-b912-a8a81dabeb3d12022-03-09
71335-1855-8EA - Each71335-1855a5b35915-d4ad-4824-9ae1-aa7b4b6beba512025-10-14
71335-1855-9EA - Each71335-18558b3e40db-b4dd-42c1-b4b2-96109efaff3712023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1855ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20240823_8585e68b-965f-4f95-a5df-eea023cd5f82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN8585e68b-965f-4f95-a5df-eea023cd5f82105
198052ondansetron 4 MG Oral TabletSCD8585e68b-965f-4f95-a5df-eea023cd5f82105
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY8585e68b-965f-4f95-a5df-eea023cd5f82105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1855-07133518550060 TABLET, FILM COATED in 1 BOTTLE (71335-1855-0) 2021-12-210000-00-00NoNoCurrent
71335-1855-17133518550110 TABLET, FILM COATED in 1 BOTTLE (71335-1855-1) 2021-12-210000-00-00NoNoCurrent
71335-1855-2713351855023 TABLET, FILM COATED in 1 BOTTLE (71335-1855-2) 2021-12-210000-00-00NoNoCurrent
71335-1855-37133518550330 TABLET, FILM COATED in 1 BOTTLE (71335-1855-3) 2021-12-210000-00-00NoNoCurrent
71335-1855-47133518550415 TABLET, FILM COATED in 1 BOTTLE (71335-1855-4) 2021-12-210000-00-00NoNoCurrent
71335-1855-5713351855056 TABLET, FILM COATED in 1 BOTTLE (71335-1855-5) 2021-12-210000-00-00NoNoCurrent
71335-1855-6713351855064 TABLET, FILM COATED in 1 BOTTLE (71335-1855-6) 2021-12-210000-00-00NoNoCurrent
71335-1855-77133518550790 TABLET, FILM COATED in 1 BOTTLE (71335-1855-7) 2021-12-210000-00-00NoNoCurrent
71335-1855-87133518550812 TABLET, FILM COATED in 1 BOTTLE (71335-1855-8) 2021-12-210000-00-00NoNoCurrent
71335-1855-97133518550920 TABLET, FILM COATED in 1 BOTTLE (71335-1855-9) 2021-12-210000-00-00NoNoCurrent