FDA.reportPublic FDA data

Ondansetron

Product NDC
57237-078
11-digit product format
572370078
Labeler code
57237
Product ID
57237-078_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
8 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
ONDANSETRON8 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
57237-078-01Ondansetron100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10015
57237-078-10Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING315
57237-078-10Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1015
57237-078-30Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3015
57237-078-50Ondansetron500 in 1 BOTTLETABLET, ORALLY DISINTEGRATING50015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-078ONDANSETRON 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
312087ondansetron 8 MG Disintegrating Oral TabletPSNd9321ef6-9fe5-4631-9c58-534fd963cf17104
312087ondansetron 8 MG Disintegrating Oral TabletSCDd9321ef6-9fe5-4631-9c58-534fd963cf17104
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
312087ondansetron 8 MG Disintegrating Oral TabletPSN84234d20-aa73-446f-9a1b-846e0cb80cec10
312087ondansetron 8 MG Disintegrating Oral TabletSCD84234d20-aa73-446f-9a1b-846e0cb80cec10
312087ondansetron 8 MG Disintegrating Oral TabletPSN70b48280-ef74-472b-abc3-128962bfcb057
312087ondansetron 8 MG Disintegrating Oral TabletSCD70b48280-ef74-472b-abc3-128962bfcb057
312087ondansetron 8 MG Disintegrating Oral TabletPSN72f29916-0f95-102d-e053-2991aa0aa5cd6
312087ondansetron 8 MG Disintegrating Oral TabletSCD72f29916-0f95-102d-e053-2991aa0aa5cd6
312087ondansetron 8 MG Disintegrating Oral TabletPSNec6fe851-d577-5da5-e053-2a95a90a3dbc5
312087ondansetron 8 MG Disintegrating Oral TabletPSNe07c38c0-e1c2-01de-e053-2995a90a390a5
312087ondansetron 8 MG Disintegrating Oral TabletPSNd11a99e2-3af2-4f6c-b0bb-1edd1ece135c5
312087ondansetron 8 MG Disintegrating Oral TabletSCDd11a99e2-3af2-4f6c-b0bb-1edd1ece135c5
312087ondansetron 8 MG Disintegrating Oral TabletSCDec6fe851-d577-5da5-e053-2a95a90a3dbc5
312087ondansetron 8 MG Disintegrating Oral TabletSCDe07c38c0-e1c2-01de-e053-2995a90a390a5
104894ondansetron 4 MG Disintegrating Oral TabletPSNe436e361-da0f-7d6d-e053-2995a90a10e43
312087ondansetron 8 MG Disintegrating Oral TabletPSNd1f6fa30-0ac8-e951-e053-2a95a90a67543
312087ondansetron 8 MG Disintegrating Oral TabletPSN3c4cda2f-13d9-42c5-b449-77deb06c8de53
312087ondansetron 8 MG Disintegrating Oral TabletPSNe436e361-da0f-7d6d-e053-2995a90a10e43
312087ondansetron 8 MG Disintegrating Oral TabletPSN47e26779-9465-410c-96b3-091119ae62f23
104894ondansetron 4 MG Disintegrating Oral TabletSCDe436e361-da0f-7d6d-e053-2995a90a10e43
312087ondansetron 8 MG Disintegrating Oral TabletSCD3c4cda2f-13d9-42c5-b449-77deb06c8de53
312087ondansetron 8 MG Disintegrating Oral TabletSCD47e26779-9465-410c-96b3-091119ae62f23
312087ondansetron 8 MG Disintegrating Oral TabletSCDe436e361-da0f-7d6d-e053-2995a90a10e43
312087ondansetron 8 MG Disintegrating Oral TabletSCDd1f6fa30-0ac8-e951-e053-2a95a90a67543
312087ondansetron 8 MG Disintegrating Oral TabletPSNe8823f01-ad74-0dd0-e053-2a95a90aa3152
312087ondansetron 8 MG Disintegrating Oral TabletSCDe8823f01-ad74-0dd0-e053-2a95a90aa3152
312087ondansetron 8 MG Disintegrating Oral TabletPSN77397df5-5a4f-41b2-98bc-f817a1e497fc1
312087ondansetron 8 MG Disintegrating Oral TabletSCD77397df5-5a4f-41b2-98bc-f817a1e497fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-078-0157237007801100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-01) 2024-09-30NoNoCurrent
57237-078-10572370078103 BLISTER PACK in 1 CARTON (57237-078-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2010-04-120000-00-00NoNoCurrent
57237-078-305723700783030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-30) 2010-04-120000-00-00NoNoCurrent
57237-078-5057237007850500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57237-078-50) 2024-09-30NoNoCurrent