Ondansetron

Product NDC
0781-5239
11-digit product format
007815239
Labeler code
0781
Product ID
0781-5239_ab451abb-8fef-494f-99b0-6529c55a48c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA078050
Marketing category
ANDA
Marketing start
2007-08-13
Marketing end
2020-12-31
Substance
ONDANSETRON
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5239-06EA - Each0781-5239411f46a5-62a2-4f80-bca5-97d58950343512012-07-24
0781-5239-64EA - Each0781-52396ca0a09d-a9ba-40d5-bf49-e52f5d11c27412012-07-24
0781-5239-80EA - Each0781-52396649420a-a891-45c7-aac7-676dddad1de412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
STRAWBERRYINACTIVE INGREDIENT4J2TY8Y81VONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [DIRECT RX]4
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]2
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN14752e63-c7a7-4400-825b-ddab1ab9e7824
312087ondansetron 8 MG Disintegrating Oral TabletSCD14752e63-c7a7-4400-825b-ddab1ab9e7824
104894ondansetron 4 MG Disintegrating Oral TabletPSNca09dd2c-02ed-4d26-af3c-aaff4120887e2
312087ondansetron 8 MG Disintegrating Oral TabletPSNca09dd2c-02ed-4d26-af3c-aaff4120887e2
104894ondansetron 4 MG Disintegrating Oral TabletSCDca09dd2c-02ed-4d26-af3c-aaff4120887e2
312087ondansetron 8 MG Disintegrating Oral TabletSCDca09dd2c-02ed-4d26-af3c-aaff4120887e2