FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
10544-575
11-digit product format
105440575
Labeler code
10544
Product ID
10544-575_0fd95943-e484-3fea-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2013-12-17
Marketing end
0000-00-00
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
10544-575-062020-01-31C16284748780-19d75b9d0-5a9d-f424-e053-dadaa90a57ceOndansetron Tablets,USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-575-06Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-575-06EA - Each10544-5753fb3f8a4-ab0c-4b93-a8e7-093ee67794bf12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-575ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150224_0fd85527-b06d-3f4a-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN0fd85527-b06d-3f4a-e054-00144ff8d46c2
312086ondansetron 8 MG Oral TabletSCD0fd85527-b06d-3f4a-e054-00144ff8d46c2
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY0fd85527-b06d-3f4a-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-575-06105440575066 in 1 BOTTLEHistorical