ONDANSETRON

Product NDC
61919-464
11-digit product format
619190464
Labeler code
61919
Product ID
61919-464_2690242c-d219-5487-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077851
Marketing category
ANDA
Marketing start
2014-01-01
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
E
Listing certified through
2017-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-464-10ONDANSETRON10 in 1 BOTTLETABLET, FILM COATED105
61919-464-30ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-464-10EA - Each61919-464bc3e1f7f-d590-4dd9-8176-03d2a2ec13d912014-07-02
61919-464-30EA - Each61919-464dc2ab39f-835c-4376-9dd7-c78a9707b24512014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON TABLET, FILM COATED [DIRECT RX]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, FILM COATED [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, FILM COATED [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON TABLET, FILM COATED [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, FILM COATED [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON TABLET, FILM COATED [DIRECT RX]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-464ONDANSETRON TABLET, FILM COATED [DIRECT RX]5Legacy NDC, 2 package rows20161025_4eb5d64c-89ff-4ee4-98ca-487866b8f2e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN4eb5d64c-89ff-4ee4-98ca-487866b8f2e75
198052ondansetron 4 MG Oral TabletSCD4eb5d64c-89ff-4ee4-98ca-487866b8f2e75
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY4eb5d64c-89ff-4ee4-98ca-487866b8f2e75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-464-106191904641010 in 1 BOTTLEHistorical
61919-464-306191904643030 in 1 BOTTLEHistorical