FDA.reportPublic FDA data

ONDANSETRON

Product NDC
63304-458
11-digit product format
633040458
Labeler code
63304
Product ID
63304-458_ad113c32-f57c-4548-9882-c46b9a990bd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-06-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ONDANSETRON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052, 312086

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
63304-458-30ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-458-30EA - Each63304-45808c42617-c011-4822-897e-e8b6c8bae7d512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON TABLET, FILM COATED [PROFICIENT RX LP]2
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON TABLET, FILM COATED [DIRECT RX]1
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, FILM COATED [DIRECT RX]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, FILM COATED [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON TABLET, FILM COATED [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON TABLET, FILM COATED [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON TABLET, FILM COATED [DIRECT RX]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON TABLET, FILM COATED [DIRECT RX]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-458ONDANSETRON TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]2Current NDC, Legacy NDC, 1 package rows20190919_834bc56a-657d-4733-9a60-47040cb5c7bf.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
198052ondansetron HCl 4 MG Oral TabletPSN41c0dc3d-a616-425e-9073-625a0cb692c44
312086ondansetron HCl 8 MG Oral TabletPSN41c0dc3d-a616-425e-9073-625a0cb692c44
198052ondansetron 4 MG Oral TabletSCD41c0dc3d-a616-425e-9073-625a0cb692c44
312086ondansetron 8 MG Oral TabletSCD41c0dc3d-a616-425e-9073-625a0cb692c44
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY41c0dc3d-a616-425e-9073-625a0cb692c44
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY41c0dc3d-a616-425e-9073-625a0cb692c44
198052ondansetron HCl 4 MG Oral TabletPSN834bc56a-657d-4733-9a60-47040cb5c7bf2
312086ondansetron HCl 8 MG Oral TabletPSN834bc56a-657d-4733-9a60-47040cb5c7bf2
198052ondansetron 4 MG Oral TabletSCD834bc56a-657d-4733-9a60-47040cb5c7bf2
312086ondansetron 8 MG Oral TabletSCD834bc56a-657d-4733-9a60-47040cb5c7bf2
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY834bc56a-657d-4733-9a60-47040cb5c7bf2
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY834bc56a-657d-4733-9a60-47040cb5c7bf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-458-306330404583030 TABLET, FILM COATED in 1 BOTTLE (63304-458-30) 2007-06-250000-00-00NoNoCurrent