FDA.reportPublic FDA data

ondansetron

Product NDC
50436-0132
11-digit product format
504360132
Labeler code
50436
Product ID
50436-0132_45e452bf-f06c-4f85-ba9f-d51c7fadc497
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-06-25
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
2020-12-31
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
50436-0132-12021-01-29C16284748780-1ba0f9c33-0d78-a910-e053-dadaa90a0b8597c00a1d-1ac5-4eae-ad65-71ff5b1413e4
50436-0132-42021-01-29C16284748780-1ba0f9c33-0d78-a910-e053-dadaa90a0b8597c00a1d-1ac5-4eae-ad65-71ff5b1413e4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0132-1ondansetron30 in 1 BOTTLETABLET, FILM COATED308
50436-0132-4ondansetron10 in 1 BOTTLETABLET, FILM COATED108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0132-1EA - Each50436-013200bcc47f-1908-4136-b505-dadfdce8ce8d12015-10-02
50436-0132-4EA - Each50436-013293091a79-2a95-4ab9-85d9-54ce9a7dec0f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0132ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES]8Legacy NDC, 2 package rows20161207_97c00a1d-1ac5-4eae-ad65-71ff5b1413e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN97c00a1d-1ac5-4eae-ad65-71ff5b1413e48
198052ondansetron 4 MG Oral TabletSCD97c00a1d-1ac5-4eae-ad65-71ff5b1413e48
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY97c00a1d-1ac5-4eae-ad65-71ff5b1413e48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0132-15043601320130 in 1 BOTTLEHistorical
50436-0132-45043601320410 in 1 BOTTLEHistorical