FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
33261-745
11-digit product format
332610745
Labeler code
33261
Product ID
33261-745_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
8 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
33261-745-052020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-745-062020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-745-102020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-745-122020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-745-202020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP
33261-745-302020-01-31C16284748780-19d75b9d0-1e0d-f424-e053-dadaa90a57ceOndansetron Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-745-05Ondansetron Hydrochloride5 in 1 BOTTLE, PLASTICTABLET, FILM COATED51
33261-745-06Ondansetron Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED61
33261-745-10Ondansetron Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED101
33261-745-12Ondansetron Hydrochloride12 in 1 BOTTLE, PLASTICTABLET, FILM COATED121
33261-745-20Ondansetron Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED201
33261-745-30Ondansetron Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-745-05EA - Each33261-745503e1ff0-83d9-474b-a73f-c632ca2cf7bf12016-09-02
33261-745-06EA - Each33261-745be9cc7ce-e81f-444e-8314-c598bab6bcd412015-10-02
33261-745-10EA - Each33261-74587a3f1d9-0d51-4768-a26d-566bc148f8dc12015-10-02
33261-745-12EA - Each33261-74558fc3c79-e051-4f13-a079-739d2848d63b12015-10-02
33261-745-20EA - Each33261-745e9c74575-a1b2-4bb4-924b-ea5b0c2be6b812015-10-02
33261-745-30EA - Each33261-745491e8fbc-ed85-48d5-83e3-1ed7ee5b32bf12015-10-02

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
33261-745ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 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
33261-745-05332610745055 in 1 BOTTLE, PLASTICHistorical
33261-745-06332610745066 in 1 BOTTLE, PLASTICHistorical
33261-745-103326107451010 in 1 BOTTLE, PLASTICHistorical
33261-745-123326107451212 in 1 BOTTLE, PLASTICHistorical
33261-745-203326107452020 in 1 BOTTLE, PLASTICHistorical
33261-745-303326107453030 in 1 BOTTLE, PLASTICHistorical