FDA.reportPublic FDA data

ondansetron

Product NDC
55154-7879
11-digit product format
551547879
Labeler code
55154
Product ID
55154-7879_40b3462a-3eba-414d-a595-63f462199bd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076183
Marketing category
ANDA
Marketing start
2006-12-26
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052, 312086

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
55154-7879-02023-02-28C16284748780-1ba0f9c33-4491-a910-e053-dadaa90a0b85These 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
55154-7879-02021-01-29C16284748780-1ba0f9c33-4491-a910-e053-dadaa90a0b85These 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
55154-7879-0ondansetron1 in 1 BLISTER PACKTABLET, FILM COATED16
55154-7879-0ondansetron10 in 1 BAGTABLET, FILM COATED106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7879ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 2 package rows20250507_cb02f2d7-31a9-4f12-880e-7ce7d85440d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNcb02f2d7-31a9-4f12-880e-7ce7d85440d46
312086ondansetron HCl 8 MG Oral TabletPSNcb02f2d7-31a9-4f12-880e-7ce7d85440d46
198052ondansetron 4 MG Oral TabletSCDcb02f2d7-31a9-4f12-880e-7ce7d85440d46
312086ondansetron 8 MG Oral TabletSCDcb02f2d7-31a9-4f12-880e-7ce7d85440d46
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYcb02f2d7-31a9-4f12-880e-7ce7d85440d46
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYcb02f2d7-31a9-4f12-880e-7ce7d85440d46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-7879-05515478790010 BLISTER PACK in 1 BAG (55154-7879-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2006-12-26NoNoHistorical