FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
50090-4671
11-digit product format
500904671
Labeler code
50090
Product ID
50090-4671_1f419776-f8b7-40fd-aaea-038d16459e4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
Substance
ONDANSETRON HYDROCHLORIDE
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui312086

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
50090-4671-02023-02-07C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
50090-4671-12023-02-07C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
50090-4671-22023-02-07C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
50090-4671-32023-02-07C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
50090-4671-42023-02-07C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
50090-4671-02023-01-30C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
50090-4671-12023-01-30C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
50090-4671-22023-01-30C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
50090-4671-32023-01-30C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991
50090-4671-42023-01-30C16284748780-1f386c64a-3c08-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS. ONDANSETRON tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4671-0Ondansetron Hydrochloride4 in 1 BOTTLETABLET, FILM COATED414
50090-4671-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED1014
50090-4671-2Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED314
50090-4671-3Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3014
50090-4671-4Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED614

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4671-0EA - Each50090-4671f643cedb-bf64-437c-a80b-5fc842f48cde12024-03-12
50090-4671-1EA - Each50090-467107a2a483-d85b-4890-8b40-d4667d8cbc8f12024-03-12
50090-4671-2EA - Each50090-467116252a5e-6fb7-46fb-aace-da9480db522412024-03-12
50090-4671-3EA - Each50090-467107fc2986-26e6-4256-a101-e719804823c412024-03-12
50090-4671-4EA - Each50090-46710766296f-125f-4b89-baa8-95866c39eebd12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4671ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 5 package rows20240210_e0f69f57-aeb9-4890-85aa-e5976208e8be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSNe0f69f57-aeb9-4890-85aa-e5976208e8be14
312086ondansetron 8 MG Oral TabletSCDe0f69f57-aeb9-4890-85aa-e5976208e8be14
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYe0f69f57-aeb9-4890-85aa-e5976208e8be14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4671-0500904671004 TABLET, FILM COATED in 1 BOTTLE (50090-4671-0) 2019-11-010000-00-00NoNoCurrent
50090-4671-15009046710110 TABLET, FILM COATED in 1 BOTTLE (50090-4671-1) 2019-11-010000-00-00NoNoCurrent
50090-4671-2500904671023 TABLET, FILM COATED in 1 BOTTLE (50090-4671-2) 2019-11-010000-00-00NoNoCurrent
50090-4671-35009046710330 TABLET, FILM COATED in 1 BOTTLE (50090-4671-3) 2019-11-010000-00-00NoNoCurrent
50090-4671-4500904671046 TABLET, FILM COATED in 1 BOTTLE (50090-4671-4) 2019-11-010000-00-00NoNoCurrent