FDA.reportPublic FDA data

ondansetron

Product NDC
62756-240
11-digit product format
627560240
Labeler code
62756
Product ID
62756-240_e83d90db-54a7-4c13-bd68-b1620a8aecaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077557
Marketing category
ANDA
Marketing start
2007-08-02
Substance
ONDANSETRON
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
ONDANSETRON4 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
62756-240-64ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1018
62756-240-64ondansetron3 in 1 DOSE PACKTABLET, ORALLY DISINTEGRATING318
62756-240-83ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3018
62756-240-64ONDANSETRON3 in 1 DOSE PACKTABLET, ORALLY DISINTEGRATING35
62756-240-64ONDANSETRON10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING105
62756-240-83ONDANSETRON30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-240-64EA - Each62756-2408f6b8e8b-7703-4279-962c-3051a251446b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH]2
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH]2
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH]2
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [CARDINAL HEALTH]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
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
GLYCERYL DISTEARATEINACTIVE INGREDIENT73071MW2KMONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UONDANSETRON TABLET, ORALLY DISINTEGRATING [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-240ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES, INC.]17Current NDC, Legacy NDC, 3 package rows20250419_92c758a3-e749-4a15-be4b-ee30b364b2b0.zip
62756-240ONDANSETRON TABLET, ORALLY DISINTEGRATING [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]5Current NDC, Legacy NDC, 3 package rows20150505_52dc6871-47d3-11dc-99cc-f742b487c00e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN92c758a3-e749-4a15-be4b-ee30b364b2b018
312087ondansetron 8 MG Disintegrating Oral TabletPSN92c758a3-e749-4a15-be4b-ee30b364b2b018
198052ondansetron HCl 4 MG Oral TabletPSN92c758a3-e749-4a15-be4b-ee30b364b2b018
312086ondansetron HCl 8 MG Oral TabletPSN92c758a3-e749-4a15-be4b-ee30b364b2b018
104894ondansetron 4 MG Disintegrating Oral TabletSCD92c758a3-e749-4a15-be4b-ee30b364b2b018
198052ondansetron 4 MG Oral TabletSCD92c758a3-e749-4a15-be4b-ee30b364b2b018
312087ondansetron 8 MG Disintegrating Oral TabletSCD92c758a3-e749-4a15-be4b-ee30b364b2b018
312086ondansetron 8 MG Oral TabletSCD92c758a3-e749-4a15-be4b-ee30b364b2b018
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY92c758a3-e749-4a15-be4b-ee30b364b2b018
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY92c758a3-e749-4a15-be4b-ee30b364b2b018
104894ondansetron 4 MG Disintegrating Oral TabletPSN26aff90c-49ea-46ac-bbf3-c188c2b061c99
104894ondansetron 4 MG Disintegrating Oral TabletSCD26aff90c-49ea-46ac-bbf3-c188c2b061c99
104894ondansetron 4 MG Disintegrating Oral TabletPSN8d763a30-c778-4560-82a0-91e7b99c8e856
104894ondansetron 4 MG Disintegrating Oral TabletSCD8d763a30-c778-4560-82a0-91e7b99c8e856
104894ondansetron 4 MG Disintegrating Oral TabletPSN52dc6871-47d3-11dc-99cc-f742b487c00e5
312087ondansetron 8 MG Disintegrating Oral TabletPSN52dc6871-47d3-11dc-99cc-f742b487c00e5
104894ondansetron 4 MG Disintegrating Oral TabletSCD52dc6871-47d3-11dc-99cc-f742b487c00e5
312087ondansetron 8 MG Disintegrating Oral TabletSCD52dc6871-47d3-11dc-99cc-f742b487c00e5
104894ondansetron 4 MG Disintegrating Oral TabletPSN9913ed0c-aaad-45e1-b522-98ad170c2e8a3
104894ondansetron 4 MG Disintegrating Oral TabletSCD9913ed0c-aaad-45e1-b522-98ad170c2e8a3
104894ondansetron 4 MG Disintegrating Oral TabletPSN6c450150-a7a4-46f3-b62a-848eeefada061
312087ondansetron 8 MG Disintegrating Oral TabletPSN6c450150-a7a4-46f3-b62a-848eeefada061
104894ondansetron 4 MG Disintegrating Oral TabletSCD6c450150-a7a4-46f3-b62a-848eeefada061
312087ondansetron 8 MG Disintegrating Oral TabletSCD6c450150-a7a4-46f3-b62a-848eeefada061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-240-64627560240643 BLISTER PACK in 1 DOSE PACK (62756-240-64) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2007-08-020000-00-00NoNoCurrent
62756-240-836275602408330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-240-83) 2007-08-020000-00-00NoNoCurrent