FDA.reportPublic FDA data

Ondansetron

Product NDC
68462-105
11-digit product format
684620105
Labeler code
68462
Product ID
68462-105_32177a6a-8c35-4e1c-b7f5-7376b1c1316a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA077535
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B, 4AF302ESOS
Rxcui104894, 198052, 312086, 312087

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
68462-105-30Ondansetron30 in 1 BOTTLETABLET, FILM COATED3017
68462-105-33Ondansetron3 in 1 BLISTER PACKTABLET, FILM COATED317
68462-105-33Ondansetron1 in 1 CARTONTABLET, FILM COATED117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-105-30EA - Each68462-105c54eb966-ba3d-46bf-8a3b-a26b6ad3218912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]10
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON TABLET, FILM COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-105ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]16Current NDC, Legacy NDC, 3 package rows20240104_eee5217a-eba8-463a-812d-bf3c66f0934f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNeee5217a-eba8-463a-812d-bf3c66f0934f17
312087ondansetron 8 MG Disintegrating Oral TabletPSNeee5217a-eba8-463a-812d-bf3c66f0934f17
198052ondansetron HCl 4 MG Oral TabletPSNeee5217a-eba8-463a-812d-bf3c66f0934f17
312086ondansetron HCl 8 MG Oral TabletPSNeee5217a-eba8-463a-812d-bf3c66f0934f17
104894ondansetron 4 MG Disintegrating Oral TabletSCDeee5217a-eba8-463a-812d-bf3c66f0934f17
198052ondansetron 4 MG Oral TabletSCDeee5217a-eba8-463a-812d-bf3c66f0934f17
312087ondansetron 8 MG Disintegrating Oral TabletSCDeee5217a-eba8-463a-812d-bf3c66f0934f17
312086ondansetron 8 MG Oral TabletSCDeee5217a-eba8-463a-812d-bf3c66f0934f17
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYeee5217a-eba8-463a-812d-bf3c66f0934f17
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYeee5217a-eba8-463a-812d-bf3c66f0934f17
198052ondansetron HCl 4 MG Oral TabletPSN300b1916-a3d8-0220-e063-6394a90a6f554
198052ondansetron 4 MG Oral TabletSCD300b1916-a3d8-0220-e063-6394a90a6f554
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY300b1916-a3d8-0220-e063-6394a90a6f554
198052ondansetron HCl 4 MG Oral TabletPSNddf0ba8e-fc37-4829-b55c-9a1a62288dfd1
198052ondansetron 4 MG Oral TabletSCDddf0ba8e-fc37-4829-b55c-9a1a62288dfd1
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYddf0ba8e-fc37-4829-b55c-9a1a62288dfd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-105-306846201053030 TABLET, FILM COATED in 1 BOTTLE (68462-105-30) 2007-06-250000-00-00NoNoCurrent
68462-105-33684620105331 BLISTER PACK in 1 CARTON (68462-105-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2007-06-250000-00-00NoNoCurrent