FDA.reportPublic FDA data

ondansetron

Product NDC
67877-169
11-digit product format
678770169
Labeler code
67877
Product ID
67877-169_e6bdf195-1cf2-4064-8432-45ffdb0d2b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
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
67877-169-302024-01-30C16284748780-11030e365-4d73-111a-e063-dadaa90a10e22edc0788-dc38-4d21-ba8e-71f159e2d3b1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-169-30ondansetron30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-169-30EA - Each67877-16940ad725b-8986-4eb8-be99-2e2536493efc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
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
67877-169ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]9Legacy NDC, 1 package rows20190116_2edc0788-dc38-4d21-ba8e-71f159e2d3b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN2edc0788-dc38-4d21-ba8e-71f159e2d3b19
312086ondansetron HCl 8 MG Oral TabletPSN2edc0788-dc38-4d21-ba8e-71f159e2d3b19
198052ondansetron 4 MG Oral TabletSCD2edc0788-dc38-4d21-ba8e-71f159e2d3b19
312086ondansetron 8 MG Oral TabletSCD2edc0788-dc38-4d21-ba8e-71f159e2d3b19
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY2edc0788-dc38-4d21-ba8e-71f159e2d3b19
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2edc0788-dc38-4d21-ba8e-71f159e2d3b19
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
198052ondansetron HCl 4 MG Oral TabletPSN37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
312086ondansetron HCl 8 MG Oral TabletPSN37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
198052ondansetron 4 MG Oral TabletSCD37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
312086ondansetron 8 MG Oral TabletSCD37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
198052ondansetron HCl 4 MG Oral TabletPSN4fcfc585-78de-2dce-e054-00144ff88e883
198052ondansetron 4 MG Oral TabletSCD4fcfc585-78de-2dce-e054-00144ff88e883
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY4fcfc585-78de-2dce-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-169-306787701693030 TABLET, FILM COATED in 1 BOTTLE (67877-169-30) 2007-06-250000-00-00NoNoCurrent