FDA.reportPublic FDA data

Ondansetron

Product NDC
68462-158
11-digit product format
684620158
Labeler code
68462
Product ID
68462-158_32177a6a-8c35-4e1c-b7f5-7376b1c1316a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
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
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
ONDANSETRON8 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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-158-11Ondansetron10 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING1017
68462-158-13Ondansetron30 in 1 BOX, UNIT-DOSETABLET, ORALLY DISINTEGRATING3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-158-11EA - Each68462-15896f07cfc-360f-4c96-9204-ff3d0e491def12012-07-24
68462-158-13EA - Each68462-158dd0a48ed-d8d2-4f34-b6e0-9b9da42240ae12012-07-24

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
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]3
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]3
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]2
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIONDANSETRON TABLET, ORALLY DISINTEGRATING [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-158ONDANSETRON TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA]16Current NDC, Legacy NDC, 2 package rows20240104_eee5217a-eba8-463a-812d-bf3c66f0934f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNd117de5f-64e5-464c-b782-de0f07e66c8e23
312087ondansetron 8 MG Disintegrating Oral TabletSCDd117de5f-64e5-464c-b782-de0f07e66c8e23
104894ondansetron 4 MG Disintegrating Oral TabletPSN5a81a39b-051b-414e-a6b0-d844de4e9ab421
312087ondansetron 8 MG Disintegrating Oral TabletPSN5a81a39b-051b-414e-a6b0-d844de4e9ab421
104894ondansetron 4 MG Disintegrating Oral TabletSCD5a81a39b-051b-414e-a6b0-d844de4e9ab421
312087ondansetron 8 MG Disintegrating Oral TabletSCD5a81a39b-051b-414e-a6b0-d844de4e9ab421
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
104894ondansetron 4 MG Disintegrating Oral TabletPSN81366c85-c6c9-4a9a-9fe5-cdd8c2d19f7411
312087ondansetron 8 MG Disintegrating Oral TabletPSN81366c85-c6c9-4a9a-9fe5-cdd8c2d19f7411
104894ondansetron 4 MG Disintegrating Oral TabletSCD81366c85-c6c9-4a9a-9fe5-cdd8c2d19f7411
312087ondansetron 8 MG Disintegrating Oral TabletSCD81366c85-c6c9-4a9a-9fe5-cdd8c2d19f7411
312087ondansetron 8 MG Disintegrating Oral TabletPSNf1a0cd50-aa4f-55bc-e053-2995a90a2d3a3
312087ondansetron 8 MG Disintegrating Oral TabletPSNf1a0ea2c-0788-4e8a-e053-2a95a90a2f323
312087ondansetron 8 MG Disintegrating Oral TabletSCDf1a0cd50-aa4f-55bc-e053-2995a90a2d3a3
312087ondansetron 8 MG Disintegrating Oral TabletSCDf1a0ea2c-0788-4e8a-e053-2a95a90a2f323
312087ondansetron 8 MG Disintegrating Oral TabletPSN41366a20-0727-0446-e063-6294a90a957f2
312087ondansetron 8 MG Disintegrating Oral TabletPSNdf736abd-9cec-4e90-e053-2995a90aab5e2
312087ondansetron 8 MG Disintegrating Oral TabletSCD41366a20-0727-0446-e063-6294a90a957f2
312087ondansetron 8 MG Disintegrating Oral TabletSCDdf736abd-9cec-4e90-e053-2995a90aab5e2
104894ondansetron 4 MG Disintegrating Oral TabletPSN366b4f74-02aa-4f67-a7cb-7362e60e10521
312087ondansetron 8 MG Disintegrating Oral TabletPSNc286dba1-e6b1-4cf0-936d-9af42d8eedc31
312087ondansetron 8 MG Disintegrating Oral TabletPSN4575d288-be0c-f6c3-e063-6294a90af7081
312087ondansetron 8 MG Disintegrating Oral TabletPSN40d9cc46-aced-4866-812b-7d82933596ae1
312087ondansetron 8 MG Disintegrating Oral TabletPSN366b4f74-02aa-4f67-a7cb-7362e60e10521
312087ondansetron 8 MG Disintegrating Oral TabletPSN1d0031f0-7def-8b7d-e063-6294a90a26f41
104894ondansetron 4 MG Disintegrating Oral TabletSCD366b4f74-02aa-4f67-a7cb-7362e60e10521
312087ondansetron 8 MG Disintegrating Oral TabletSCDc286dba1-e6b1-4cf0-936d-9af42d8eedc31
312087ondansetron 8 MG Disintegrating Oral TabletSCD1d0031f0-7def-8b7d-e063-6294a90a26f41
312087ondansetron 8 MG Disintegrating Oral TabletSCD4575d288-be0c-f6c3-e063-6294a90af7081
312087ondansetron 8 MG Disintegrating Oral TabletSCD40d9cc46-aced-4866-812b-7d82933596ae1
312087ondansetron 8 MG Disintegrating Oral TabletSCD366b4f74-02aa-4f67-a7cb-7362e60e10521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-158-116846201581110 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-11) 2007-06-270000-00-00NoNoCurrent
68462-158-136846201581330 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (68462-158-13) 2007-06-270000-00-00NoNoCurrent