FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
33261-417
11-digit product format
332610417
Labeler code
33261
Product ID
33261-417_1156d9cb-4ad2-49c0-b7ee-4b947c5dcc84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
33261-417-052020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-417-062020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-417-092020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-417-102020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-417-122020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-417-152020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-417-202020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-417-302020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-417-05Ondansetron Hydrochloride5 in 1 BOTTLE, PLASTICTABLET, FILM COATED51
33261-417-06Ondansetron Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED61
33261-417-09Ondansetron Hydrochloride9 in 1 BOTTLE, PLASTICTABLET, FILM COATED91
33261-417-10Ondansetron Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED101
33261-417-12Ondansetron Hydrochloride12 in 1 BOTTLE, PLASTICTABLET, FILM COATED121
33261-417-15Ondansetron Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED151
33261-417-20Ondansetron Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED201
33261-417-30Ondansetron Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-417-05EA - Each33261-4178bc65465-d6c1-4d02-b211-cee94d8ca57912016-09-02
33261-417-06EA - Each33261-417ec6b511e-c524-485f-b0ad-986807250d8c12015-10-02
33261-417-09EA - Each33261-417d3a4e6f2-adab-4a8e-a4d6-da6cc0d1ec8712015-10-02
33261-417-10EA - Each33261-417b90e2963-dde5-4e47-950c-069e88923bff12016-09-02
33261-417-12EA - Each33261-41723a5db30-2ff2-457b-8f0b-0cf0d53df78512015-10-02
33261-417-15EA - Each33261-41707134b00-ed6d-4992-8c80-4728974aa6b612016-09-02
33261-417-20EA - Each33261-4177e75b868-e79b-443d-9e8d-04d676db62a012015-10-02
33261-417-30EA - Each33261-41727eae9df-7e46-4bb7-9c37-1527a553dcf112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-417ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 8 package rows20140128_f51f5405-f7e2-4834-ad43-70987730a0df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNf51f5405-f7e2-4834-ad43-70987730a0df1
312086ondansetron HCl 8 MG Oral TabletPSNf51f5405-f7e2-4834-ad43-70987730a0df1
198052ondansetron 4 MG Oral TabletSCDf51f5405-f7e2-4834-ad43-70987730a0df1
312086ondansetron 8 MG Oral TabletSCDf51f5405-f7e2-4834-ad43-70987730a0df1
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYf51f5405-f7e2-4834-ad43-70987730a0df1
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYf51f5405-f7e2-4834-ad43-70987730a0df1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-417-05332610417055 in 1 BOTTLE, PLASTICHistorical
33261-417-06332610417066 in 1 BOTTLE, PLASTICHistorical
33261-417-09332610417099 in 1 BOTTLE, PLASTICHistorical
33261-417-103326104171010 in 1 BOTTLE, PLASTICHistorical
33261-417-123326104171212 in 1 BOTTLE, PLASTICHistorical
33261-417-153326104171515 in 1 BOTTLE, PLASTICHistorical
33261-417-203326104172020 in 1 BOTTLE, PLASTICHistorical
33261-417-303326104173030 in 1 BOTTLE, PLASTICHistorical