FDA.reportPublic FDA data

Ondansetron

Product NDC
50090-4632
11-digit product format
500904632
Labeler code
50090
Product ID
50090-4632_ef67ba26-cfad-4a52-81b2-c2ae62512b34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
A-S Medication Solutions
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
Rxcui312087

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4632-02023-02-07C16284748780-1f386c649-e53e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-4632-12023-02-07C16284748780-1f386c649-e53e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-4632-22023-02-07C16284748780-1f386c649-e53e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-4632-32023-02-07C16284748780-1f386c649-e53e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-4632-02023-01-30C16284748780-1f386c649-e53e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-4632-12023-01-30C16284748780-1f386c649-e53e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-4632-22023-01-30C16284748780-1f386c649-e53e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991
50090-4632-32023-01-30C16284748780-1f386c649-e53e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON ORALLY DISINTEGRATING TABLETS, safely and effectively. See full prescribing information for ONDANSETRON ORALLY DISINTEGRATING TABLETS. ONDANSETRON orally disintegrating tablets Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4632-0Ondansetron4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING410
50090-4632-1Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1010
50090-4632-1Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING310
50090-4632-2Ondansetron1 in 1 CARTONTABLET, ORALLY DISINTEGRATING110
50090-4632-2Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1010
50090-4632-3Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1010
50090-4632-3Ondansetron2 in 1 CARTONTABLET, ORALLY DISINTEGRATING210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4632-0EA - Each50090-4632fb0ca368-7fdf-4fd5-80f9-da0d016f90f612021-05-05
50090-4632-1EA - Each50090-463214d0cfff-f5a3-455f-b143-019db2d8abc212022-04-06
50090-4632-2EA - Each50090-46325c13135b-87a0-43ee-aeb7-d5e356f351ce12022-12-07
50090-4632-3EA - Each50090-4632e7937d92-fd76-4c1c-9714-0f25951e21c512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4632ONDANSETRON TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 7 package rows20231017_84234d20-aa73-446f-9a1b-846e0cb80cec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN84234d20-aa73-446f-9a1b-846e0cb80cec10
312087ondansetron 8 MG Disintegrating Oral TabletSCD84234d20-aa73-446f-9a1b-846e0cb80cec10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4632-0500904632004 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50090-4632-0) 2019-10-210000-00-00NoNoCurrent
50090-4632-1500904632013 BLISTER PACK in 1 CARTON (50090-4632-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2019-10-210000-00-00NoNoCurrent
50090-4632-2500904632021 BLISTER PACK in 1 CARTON (50090-4632-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2019-10-210000-00-00NoNoCurrent
50090-4632-3500904632032 BLISTER PACK in 1 CARTON (50090-4632-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2020-12-110000-00-00NoNoCurrent