FDA.reportPublic FDA data

Ondansetron

Product NDC
57237-077
11-digit product format
572370077
Labeler code
57237
Product ID
57237-077_49380e9c-090e-44fd-b2c9-992e25e26753
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
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
Unii4AF302ESOS
Rxcui104894, 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
57237-077-01Ondansetron100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10015
57237-077-10Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1015
57237-077-10Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING315
57237-077-30Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3015
57237-077-50Ondansetron500 in 1 BOTTLETABLET, ORALLY DISINTEGRATING50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-077-10EA - Each57237-0777e8ac5e5-7bf3-4323-95cb-8387eaa2535c12015-01-05
57237-077-30EA - Each57237-07751dcdec3-6666-47d4-ac54-5a6608c91d3612016-03-04
57237-077-50EA - Each57237-077061d1ac0-80ce-4481-86a2-f7bcfb62de7c12024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]3
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]3
ONDANSETRONACTIVE INGREDIENT4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ONDANSETRON TABLET, ORALLY DISINTEGRATING [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-077ONDANSETRON TABLET, ORALLY DISINTEGRATING [RISING PHARMA HOLDINGS, INC.]14Current NDC, Legacy NDC, 5 package rows20240730_eb74425c-c635-4d99-8e98-e63e7359fb89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNeb74425c-c635-4d99-8e98-e63e7359fb8915
312087ondansetron 8 MG Disintegrating Oral TabletPSNeb74425c-c635-4d99-8e98-e63e7359fb8915
104894ondansetron 4 MG Disintegrating Oral TabletSCDeb74425c-c635-4d99-8e98-e63e7359fb8915
312087ondansetron 8 MG Disintegrating Oral TabletSCDeb74425c-c635-4d99-8e98-e63e7359fb8915
104894ondansetron 4 MG Disintegrating Oral TabletPSNf6f2e4ee-dc8b-478d-b0d6-d192119691b710
104894ondansetron 4 MG Disintegrating Oral TabletSCDf6f2e4ee-dc8b-478d-b0d6-d192119691b710
104894ondansetron 4 MG Disintegrating Oral TabletPSNee668456-a214-4452-ab9d-ec00eaa41d798
104894ondansetron 4 MG Disintegrating Oral TabletPSN85cd0c27-788d-5fd8-e053-2a91aa0a7c698
104894ondansetron 4 MG Disintegrating Oral TabletSCDee668456-a214-4452-ab9d-ec00eaa41d798
104894ondansetron 4 MG Disintegrating Oral TabletSCD85cd0c27-788d-5fd8-e053-2a91aa0a7c698
104894ondansetron 4 MG Disintegrating Oral TabletPSNaf836a30-5e51-5c97-e053-2995a90a15b97
104894ondansetron 4 MG Disintegrating Oral TabletSCDaf836a30-5e51-5c97-e053-2995a90a15b97
104894ondansetron 4 MG Disintegrating Oral TabletPSN66ac9c17-bea7-4f8d-8a27-a1e0f9e659456
104894ondansetron 4 MG Disintegrating Oral TabletPSN889e1603-06d7-4a5e-86ed-9d758195175f6
104894ondansetron 4 MG Disintegrating Oral TabletSCD66ac9c17-bea7-4f8d-8a27-a1e0f9e659456
104894ondansetron 4 MG Disintegrating Oral TabletSCD889e1603-06d7-4a5e-86ed-9d758195175f6
104894ondansetron 4 MG Disintegrating Oral TabletPSN87fd7e8e-fd04-34ad-e053-2a95a90a236d5
104894ondansetron 4 MG Disintegrating Oral TabletPSNdb9a0d22-9339-4319-e053-2a95a90a95925
104894ondansetron 4 MG Disintegrating Oral TabletSCD87fd7e8e-fd04-34ad-e053-2a95a90a236d5
104894ondansetron 4 MG Disintegrating Oral TabletSCDdb9a0d22-9339-4319-e053-2a95a90a95925
104894ondansetron 4 MG Disintegrating Oral TabletPSNa22a94bc-4fa7-8a4e-e053-2a95a90a63084
104894ondansetron 4 MG Disintegrating Oral TabletSCDa22a94bc-4fa7-8a4e-e053-2a95a90a63084
104894ondansetron 4 MG Disintegrating Oral TabletPSN8f9fc8a2-0cfd-12f1-e053-2995a90acf3d3
104894ondansetron 4 MG Disintegrating Oral TabletPSNe436e361-da0f-7d6d-e053-2995a90a10e43
312087ondansetron 8 MG Disintegrating Oral TabletPSNe436e361-da0f-7d6d-e053-2995a90a10e43
104894ondansetron 4 MG Disintegrating Oral TabletSCD8f9fc8a2-0cfd-12f1-e053-2995a90acf3d3
104894ondansetron 4 MG Disintegrating Oral TabletSCDe436e361-da0f-7d6d-e053-2995a90a10e43
312087ondansetron 8 MG Disintegrating Oral TabletSCDe436e361-da0f-7d6d-e053-2995a90a10e43
104894ondansetron 4 MG Disintegrating Oral TabletPSNad92ffb6-dc63-48dc-9fcc-37fd3d42a75c2
104894ondansetron 4 MG Disintegrating Oral TabletPSNf4240431-b173-67d7-e053-2a95a90ac44a2
104894ondansetron 4 MG Disintegrating Oral TabletSCDad92ffb6-dc63-48dc-9fcc-37fd3d42a75c2
104894ondansetron 4 MG Disintegrating Oral TabletSCDf4240431-b173-67d7-e053-2a95a90ac44a2
104894ondansetron 4 MG Disintegrating Oral TabletPSNb72d3b7f-bff2-3ec4-e053-2995a90a67b01
104894ondansetron 4 MG Disintegrating Oral TabletPSN2a863485-a0a8-db63-e063-6294a90ab6051
104894ondansetron 4 MG Disintegrating Oral TabletPSN1d51781e-6c34-d57f-e063-6294a90a5ce21
104894ondansetron 4 MG Disintegrating Oral TabletSCDb72d3b7f-bff2-3ec4-e053-2995a90a67b01
104894ondansetron 4 MG Disintegrating Oral TabletSCD1d51781e-6c34-d57f-e063-6294a90a5ce21
104894ondansetron 4 MG Disintegrating Oral TabletSCD2a863485-a0a8-db63-e063-6294a90ab6051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-077-0157237007701100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-01) 2024-09-30NoNoHistorical
57237-077-10572370077103 BLISTER PACK in 1 CARTON (57237-077-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2010-04-120000-00-00NoNoCurrent
57237-077-305723700773030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-30) 2010-04-120000-00-00NoNoCurrent
57237-077-5057237007750500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-077-50) 2024-09-30NoNoHistorical